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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02684058
Registration number
NCT02684058
Ethics application status
Date submitted
4/02/2016
Date registered
17/02/2016
Date last updated
13/12/2023
Titles & IDs
Public title
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
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Scientific title
Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)
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Secondary ID [1]
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2015-004015-20
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Secondary ID [2]
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CDRB436G2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Astrocytoma
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Anaplastic Astrocytoma
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Astrocytoma
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Oligodendroglioma, Childhood
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Anaplastic Oligodendroglioma
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Glioblastoma
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Pilocytic Astrocytoma
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Giant Cell Astrocytoma
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Pleomorphic Xanthoastrocytoma
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Anaplastic Pleomorphic Xanthoastrocytoma
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Angiocentric Glioma
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Chordoid Glioma of Third Ventricle
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Gangliocytoma
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Ganglioglioma
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Anaplastic Ganglioglioma
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Dysplastic Gangliocytoma of Cerebrellum
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Desmoplastic Infantile Astrocytoma and Ganglioglioma
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Papillary Glioneuronal Tumor
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Rosette-forming Glioneurona Tumor
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Central Neurocytoma
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Extraventricular Neurocytoma
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Cerebellar Iponeurocytoma
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dabrafenib
Treatment: Drugs - trametinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Vincristine
Experimental: LGG cohort: dabrafenib and trametinib - Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
Active Comparator: LGG cohort: carboplatin and vincristine - Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy.
Experimental: HGG cohort: dabrafenib and trametinib - Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
Treatment: Drugs: Dabrafenib
Dabrafenib was available as 50 mg and 75 mg hard capsules and as 10 mg dispersible tablets for oral suspension. Dabrafenib was administered orally, twice daily, and was dosed based on age and weight Patients < 12 years old and = 16 kg were to be administered either the dabrafenib capsules or dabrafenib dispersible tablets for oral suspension (dose: 5.25 mg/kg/day) Patients = 12 years old and = 19 kg were to be administered either the dabrafenib capsules or dabrafenib dispersible tablets for oral suspension (dose: 4.5 mg/kg/day) Patients < 12 years old and < 16 kg were to be administered dabrafenib dispersible tablets for oral suspension (dose: 5.25 mg/kg/day) Patients =12 years old and <19 kg were to be administered dabrafenib dispersible tablets for oral suspension (dose: 4.5 mg/kg/day)
Treatment: Drugs: trametinib
Trametinib was available as 0.5 mg and 2 mg film-coated tablets and as 5.0 mg powder in bottle for oral solution (0.05 mg/ml after reconstitution with 90 ml water).Trametinib was administered orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on age and weight.
Patients <6 years old and <26 kg were to be administered the trametinib oral solution (dose: 0.032 mg/kg/day) Patients <6 years old and =26 kg were to be administered either the trametinib oral solution or trametinib tablets (dose: 0.032 mg/kg/day) Patients =6 years old and =10 kg < 33 kg were to be administered the trametinib oral solution (dose: 0.025 mg/kg/day) Patients =6 years old and =33 kg were to be administered either the trametinib oral solution or the trametinib tablets (dose: 0.025 mg/kg/day)
Treatment: Drugs: Carboplatin
Carboplatin was supplied locally as commercially available and labelled accordingly to comply with legal requirements of each country. Carboplatin was administered as one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Each maintenance cycle was 6 weeks, and consisted of 4 weeks of chemotherapy with 2 weeks of rest.
Induction: 175 mg/m^2 as weekly intravenous (IV) infusion on weeks 1 to 4, and on weeks 7 to 10, on the same day as vincristine dosing Maintenance: 175 mg/m^2 as weekly IV infusion over 60 minutes on weeks 1 to 4 of each cycle.
Treatment: Drugs: Vincristine
Vincristine was supplied locally as commercially available and labelled accordingly to comply with legal requirements of each country. Vincristine was administered as one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy.
Induction: 1.5 mg/m^2 as weekly IV bolus infusion (0.05 mg/kg if child is <12 kg) (maximum dose of 2.0 mg) for 10 weeks.
Maintenance: 1.5 mg/m^2 as weekly IV bolus infusion (0.05 mg/kg if child is <12 kg) (maximum dose of 2.0 mg) on weeks 1 to 3 of each cycle, on the same day as carboplatin dosing.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria
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Assessment method [1]
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Percentage of participants in the LGG cohort with a best overall confirmed Complete Response (CR) or Partial Response (PR) as assessed per RANO criteria by central independent assessment. The 95% confidence intervals (CIs) were computed using two-sided exact binomial method.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [1]
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Up to approximately (approx.) 3 years
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Primary outcome [2]
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HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria
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Assessment method [2]
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Percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [2]
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Up to approx. 3.2 years
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Secondary outcome [1]
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LGG Cohort: ORR by Investigator Assessment Using RANO Criteria
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Assessment method [1]
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Percentage of participants in the LGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [1]
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Up to approx. 3 years and up to approx 4.2 years
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Secondary outcome [2]
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LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [2]
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Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [2]
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Up to approx. 3 years and up to approx 4.2 years
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Secondary outcome [3]
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LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria
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Assessment method [3]
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Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [3]
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Up to approx. 3 years and up to approx 4.2 years
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Secondary outcome [4]
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LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [4]
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Time from the date of randomization to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.
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Timepoint [4]
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Up to approx. 3 years and up to approx 4.2 years
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Secondary outcome [5]
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LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Investigator Assessment Using RANO Criteria
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Assessment method [5]
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Time from the date of randomization to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.
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Timepoint [5]
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Up to approx. 3 years and up to approx 4.2 years
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Secondary outcome [6]
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LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [6]
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Time from randomization to first documented response of CR or PR as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [6]
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Up to approx. 4.2 years
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Secondary outcome [7]
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LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria
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Assessment method [7]
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Time from randomization to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [7]
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Up to approx. 4.2 years
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Secondary outcome [8]
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LGG Cohort: Clinical Benefit Rate (CBR) by Central Independent Assessment Using RANO Criteria
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Assessment method [8]
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Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
SD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.
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Timepoint [8]
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Up to approx. 4.2 years
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Secondary outcome [9]
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LGG Cohort: Clinical Benefit Rate (CBR) by Investigator Assessment Using RANO Criteria
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Assessment method [9]
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Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
SD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.
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Timepoint [9]
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Up to approx. 4.2 years
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Secondary outcome [10]
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LGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)
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Assessment method [10]
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Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.
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Timepoint [10]
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Up to 4.6 years
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Secondary outcome [11]
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LGG Cohort: 2-year OS Estimate
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Assessment method [11]
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OS was defined as the time from the first dose to death due to any cause in the LGG cohort. The 2-year Kaplan-Meier OS estimate represented the estimated percentage of participants remaining free from OS events for up to 2 years. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact
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Timepoint [11]
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2 years from first dose
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Secondary outcome [12]
0
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HGG Cohort: ORR by Investigator Assessment Using RANO Criteria
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Assessment method [12]
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ORR in the HGG cohort defined as the percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [12]
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0
Up to approx. 3.2 years and up to approx. 4.8 years
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Secondary outcome [13]
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0
HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [13]
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Time from first documented response (PR or CR) until disease progression or death as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [13]
0
0
Up to approx. 3.2 years and up to approx. 4.8 years
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Secondary outcome [14]
0
0
HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria
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Assessment method [14]
0
0
Time from first documented response (PR or CR) until disease progression or death as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [14]
0
0
Up to approx. 3.2 years and up to approx. 4.8 years
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Secondary outcome [15]
0
0
HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [15]
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Time from the date of first dose of study treatment to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.
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Timepoint [15]
0
0
Up to approx. 4.8 years
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Secondary outcome [16]
0
0
HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Investigatort Assessment Using RANO Criteria
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Assessment method [16]
0
0
Time from the date of first dose of study treatment to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.
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Timepoint [16]
0
0
Up to approx. 4.8 years
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Secondary outcome [17]
0
0
HGG Cohort: Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [17]
0
0
Time from start of treatment to first documented response of CR or PR as per independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [17]
0
0
Up to approx. 4.8 years
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Secondary outcome [18]
0
0
HGG Cohort: Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria
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Assessment method [18]
0
0
Time from start of treatment to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
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Timepoint [18]
0
0
Up to approx. 4.8 years
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Secondary outcome [19]
0
0
HGG Cohort: Clinical Benefit Rate (CBR) as Per Central Independent Assessment Using RANO Criteria
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Assessment method [19]
0
0
Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
SD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.
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Timepoint [19]
0
0
Up to approx. 4.8 years
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Secondary outcome [20]
0
0
HGG Cohort: Clinical Benefit Rate (CBR) as Per Investigator Assessment Using RANO Criteria
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Assessment method [20]
0
0
Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.
CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.
PR: = 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
SD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.
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Timepoint [20]
0
0
Up to approx. 4.8 years
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Secondary outcome [21]
0
0
HGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)
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Assessment method [21]
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0
Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.
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Timepoint [21]
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0
Up to 5.1 years
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Secondary outcome [22]
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0
AUClast for Trametinib
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Assessment method [22]
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Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).
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Timepoint [22]
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0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
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Secondary outcome [23]
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0
Cmax for Trametinib
Query!
Assessment method [23]
0
0
PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration
Query!
Timepoint [23]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [24]
0
0
AUCtau for Trametinib
Query!
Assessment method [24]
0
0
PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state
Query!
Timepoint [24]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [25]
0
0
Tmax for Trametinib
Query!
Assessment method [25]
0
0
PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.
Query!
Timepoint [25]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [26]
0
0
T1/2 for Trametinib
Query!
Assessment method [26]
0
0
PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life
Query!
Timepoint [26]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [27]
0
0
Ctrough for Trametinib
Query!
Assessment method [27]
0
0
PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration
Query!
Timepoint [27]
0
0
Week 3 Day 1 pre-dose
Query!
Secondary outcome [28]
0
0
AUClast for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Query!
Assessment method [28]
0
0
PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).
Query!
Timepoint [28]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [29]
0
0
Cmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Query!
Assessment method [29]
0
0
PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration
Query!
Timepoint [29]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [30]
0
0
AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Query!
Assessment method [30]
0
0
PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state
Query!
Timepoint [30]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [31]
0
0
Tmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Query!
Assessment method [31]
0
0
PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.
Query!
Timepoint [31]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [32]
0
0
T1/2 for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Query!
Assessment method [32]
0
0
PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life
Query!
Timepoint [32]
0
0
Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose
Query!
Secondary outcome [33]
0
0
Ctrough for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)
Query!
Assessment method [33]
0
0
PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration
Query!
Timepoint [33]
0
0
Week 3 Day 1 pre-dose
Query!
Secondary outcome [34]
0
0
HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth
Query!
Assessment method [34]
0
0
Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on how it tasted before rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [34]
0
0
Week 1 and Week 5
Query!
Secondary outcome [35]
0
0
HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth
Query!
Assessment method [35]
0
0
Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on how it tasted before rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [35]
0
0
Week 1 and Week 5
Query!
Secondary outcome [36]
0
0
HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed
Query!
Assessment method [36]
0
0
Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after the medication was swallowed, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [36]
0
0
Week 1 and Week 5
Query!
Secondary outcome [37]
0
0
HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed
Query!
Assessment method [37]
0
0
Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after the medication was swallowed, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [37]
0
0
Week 1 and Week 5
Query!
Secondary outcome [38]
0
0
HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Immediate Reaction Once the Medication Was Placed Into the Mouth
Query!
Assessment method [38]
0
0
Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [38]
0
0
Week 1 and Week 5
Query!
Secondary outcome [39]
0
0
HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: Immediate Reaction Once the Medication Was Placed Into the Mouth
Query!
Assessment method [39]
0
0
Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [39]
0
0
Week 1 and Week 5
Query!
Secondary outcome [40]
0
0
HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Remaining After-taste Once Rinsing the Mouth With Water
Query!
Assessment method [40]
0
0
Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [40]
0
0
Week 1 and Week 5
Query!
Secondary outcome [41]
0
0
HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: Remaining After-taste Once Rinsing the Mouth With Water
Query!
Assessment method [41]
0
0
Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.
Query!
Timepoint [41]
0
0
Week 1 and Week 5
Query!
Secondary outcome [42]
0
0
LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Global Health Score
Query!
Assessment method [42]
0
0
The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 7 items measuring the global health of the patient. 4 items used a 5-level Likert scale with 1=poor and 5=excellent; 1 item used a 5-level Likert scale with 1=never and 5=always; and 2 items used a 5-level Likert scale with 1=never and 5=almost always. The total raw global health score, ranging from 7 to 35, was computed by summing item values, with higher scores indicating better overall well-being. Raw scores were then transformed into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores reflected better global health status.
Participants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.
Query!
Timepoint [42]
0
0
Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)
Query!
Secondary outcome [43]
0
0
LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Pain Score
Query!
Assessment method [43]
0
0
The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the pain of the participants. Pain item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening pain. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated more severe pain experiences.
Participants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.
Query!
Timepoint [43]
0
0
Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)
Query!
Secondary outcome [44]
0
0
LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Fatigue Score
Query!
Assessment method [44]
0
0
The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the fatigue interference of the participants. Fatigue item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening fatigue. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated a greater level of reported fatigue.
Participants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.
Query!
Timepoint [44]
0
0
Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)
Query!
Eligibility
Key inclusion criteria
Key
- Diagnosis of BRAF V600 mutant High Grade glioma that had relapsed, progressed or
failed to respond to frontline therapy
- Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following
surgical excision, or non-surgical candidates with necessity to begin first systemic
treatment because of a risk of neurological impairment with progression.
- Confirmed measurable disease
Key
Query!
Minimum age
12
Months
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK
inhibitor
- HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic
therapy or radiotherapy prior to enrollment
- LGG patients: history of allergic reaction or contraindications to the use of
carboplatin or vincristine
- Stem cell transplant within the past 3 months
- History of heart disease
- Pregnant or lactating females
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/12/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/04/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
151
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Randwick
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2130 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Buenos Aires
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Brussels
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
SP
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
British Columbia
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Brno
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Praha 5
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Copenhagen
Query!
Country [20]
0
0
Finland
Query!
State/province [20]
0
0
Tampere
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Lille Cedex
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Lyon
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Paris
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Strasbourg
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Toulouse Cedex
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Villejuif
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Augsburg
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Berlin
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Essen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Gottingen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hamburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Heidelberg
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Koeln
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Petach-Tikva
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Tel-Hashomer
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
FI
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
GE
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
MI
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
RM
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
TO
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Fukuoka
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Tokyo
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Osaka
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
CS
Query!
Country [45]
0
0
Russian Federation
Query!
State/province [45]
0
0
Moscow
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Catalunya
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Madrid
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Valencia
Query!
Country [49]
0
0
Sweden
Query!
State/province [49]
0
0
Stockholm
Query!
Country [50]
0
0
Switzerland
Query!
State/province [50]
0
0
Zuerich
Query!
Country [51]
0
0
United Kingdom
Query!
State/province [51]
0
0
Leeds
Query!
Country [52]
0
0
United Kingdom
Query!
State/province [52]
0
0
Liverpool
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study was to investigate the activity of dabrafenib in combination with
trametinib in children and adolescent patients with BRAF V600 mutation positive low grade
glioma (LGG) or relapsed or refractory high grade glioma (HGG)
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02684058
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02684058
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