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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/NCT01677741
Registration number
NCT01677741
Ethics application status
Date submitted
30/08/2012
Date registered
3/09/2012
Date last updated
24/11/2021
Titles & IDs
Public title
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
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Scientific title
Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors
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Secondary ID [1]
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2012-001499-12
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Secondary ID [2]
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116013
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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:
Neoplasms, Brain
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dabrafenib
Experimental: Part 1: Dabrafenib treatment - Three subjects will receive a single dose of 3 mg/kg dabrafenib on Day 1 and repeat dose will begin from Day 2, evenly divided in two daily doses. Once all 3 subjects have been fully evaluated for the first 28 days (including Day 15 PK) and no DLTs are observed, a next subject will be enrolled at the next higher dose levels (i.e., dose escalation to 3.75 mg/kg [+1] and may be further to 4.5 mg/kg [+2] and so on). If all 3 subjects have not been fully evaluated for the first 28 days or 1 DLT occurred, the fourth subject will be enrolled at the same dose level. If 2 or more DLTs are observed, the next subject will be enrolled at the next lower dose level (i.e., de-escalated to 2.25 mg/kg [-1] and may be further to 1.5 mg/kg [-2]). Similarly, the process is repeated for the fifth and sixth subjects in a cohort. All subjects will receive treatment till end of study.
Experimental: Part 2: Cohort 1 Low-Grade Gliomas with BRAF V600 mutations - Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
Experimental: Part 2: Cohort 2 High-Grade Gliomas with BRAF V600 mutations - Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
Experimental: Part 2: Cohort 3 LCH with BRAF V600 mutations - Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
Experimental: Part 2: Cohort 4 Melanoma and PTC with BRAF V600 mutations - Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
Treatment: Drugs: Dabrafenib
Dabrafenib is available as 50 mg or 75 mg capsules and as oral suspension (10 mg/mL for subjects unable to swallow capsules). Dabrafenib (either formulation) will be administered orally as a single dose on Day 1 and twice daily from Day 2, based on weight at the appropriate study dose level.
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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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Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
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Assessment method [1]
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The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
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Timepoint [1]
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From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months
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Primary outcome [2]
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Maximum Concentration (Cmax) of Dabrafenib
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Assessment method [2]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics.
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Timepoint [2]
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Week 1 Day 1, Week 3 Day 15
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Primary outcome [3]
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Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-t)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib
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Assessment method [3]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-t) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics.
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Timepoint [3]
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Week 1 Day 1
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Secondary outcome [1]
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Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites
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Assessment method [1]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).
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Timepoint [1]
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Week 3 Day 15
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Secondary outcome [2]
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The AUC(0-t) of Dabrafenib Metabolites
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Assessment method [2]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.
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Timepoint [2]
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Week 1 Day 1, Week 3 Day 15
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Secondary outcome [3]
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The AUC(0-tau) of Dabrafenib and Its Metabolites
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Assessment method [3]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.
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Timepoint [3]
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Week 1 Day 1, Week 3 Day 15
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Secondary outcome [4]
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Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib
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Assessment method [4]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics.
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Timepoint [4]
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Week 1 Day 1, Week 3 Day 15
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Secondary outcome [5]
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Maximum Concentration (Cmax) of Dabrafenib Metabolites
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Assessment method [5]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were listed and summarized using descriptive statistics.
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Timepoint [5]
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Week 1 Day 1, Week 3 Day 15
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Secondary outcome [6]
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Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
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Assessment method [6]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).
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Timepoint [6]
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Week 1 Day 1, Week 3 Day 15
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Secondary outcome [7]
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Elimination Half Life (T½) of Dabrafenib and Its Metabolites
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Assessment method [7]
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Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) was listed and summarized using descriptive statistics.
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Timepoint [7]
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Week 3 Day 15
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Secondary outcome [8]
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Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
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Assessment method [8]
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The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Event and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
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Timepoint [8]
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From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months
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Secondary outcome [9]
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Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for Low Grade Glioma (LLG) Subjects
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Assessment method [9]
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Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.
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Timepoint [9]
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Up to 6 months
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Secondary outcome [10]
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Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for High Grade Glioma (HGG) Subjects
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Assessment method [10]
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Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.
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Timepoint [10]
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Up to 6 months
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Secondary outcome [11]
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Effect of Weight on Total Apparent Clearance (CL/F) of Dabrafenib Estimated With a PopPK Model
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Assessment method [11]
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The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on total apparent clearance (CL/F) of dabrafenib estimated with the PopPK model is summarized in this record.
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Timepoint [11]
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Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
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Secondary outcome [12]
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Effect of Weight on Volume of Distribution (V/F) of Dabrafenib Estimated With a PopPK Model
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Assessment method [12]
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The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on volume of distribution (V/F) of dabrafenib estimated with the PopPK model is summarized in this record.
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Timepoint [12]
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Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
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Secondary outcome [13]
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Effect of Weight on Absorption Rate (ka) of Dabrafenib Estimated With a PopPK Model
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Assessment method [13]
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The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on absorption rate (ka) of dabrafenib estimated with a PopPK model is summarized in this record.
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Timepoint [13]
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Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
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Secondary outcome [14]
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Effect of Weight on Coefficients for Significant Covariates of Dabrafenib Estimated With a PopPK Model
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Assessment method [14]
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The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on coefficients for significant covariates of dabrafenib estimated with a PopPK model is summarized in this record.
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Timepoint [14]
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Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
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Eligibility
Key inclusion criteria
- Written informed consent - a signed informed consent and/or assent (as age
appropriate) will be obtained according to institutional guidelines.
- Male or female >=12 months and <18 years of age at the time of signing the informed
consent form.
- Recurrent disease, refractory disease, or progressive disease after having received at
least one standard therapy for their disease. Note: Subjects with metastatic (and
surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma
subjects with CNS involvement may be enrolled.
- At least one evaluable lesion.
- BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement
Amendments (CLIA)-approved laboratory or equivalent (the local BRAF testing may be
subject to subsequent verification by centralized testing; centralized testing can
confirm V600E and V600K mutations only).
- Performance score of >=50% according to the Karnofsky/Lansky performance status scale
(subjects with a performance status of <=50% can be enrolled if the subject's
confinement to bed and inability to carry out activities is due solely to
cancer-related pain, as assessed by the investigator).
- Females of child-bearing potential (with negative serum pregnancy test within 7 days
prior to the first dose of study medication) must be willing to practice acceptable
methods of birth control .
- Sexually active males, who do not agree to abstinence, must be willing to use a condom
during intercourse while taking the study drug, and for 16 weeks after stopping
treatment and should not father a child in this period.
- Must have adequate organ function as defined by the following values: Adequate bone
marrow function defined as-absolute neutrophil count (ANC) >=1000/ microliter (µL),
hemoglobin >=8.0 grams (g)/ deciliter (dL) (may receive red blood cell transfusions),
platelets >=75,000/µL (transfusion independent, defined as not receiving platelet
transfusions within a 7 day period prior to enrollment).
- Adequate renal and metabolic function defined as: calculated glomerular filtration
rate (eGFR) (Schwartz formula), or radioisotope GFR >=90 milliliters/minutes
(mL/min)/1.73 meter square (m^2); or a serum creatinine within the institutional
reference range upper limit of normal (for age/gender, if available).
- Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) <=1.5
x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine
transaminase (ALT) <=2.5 x ULN; AST/ALT may be <5 x ULN at baseline if disease under
treatment involves the liver (requires radiographic confirmation of liver
involvement).
- Adequate cardiac function defined as: left ventricular ejection fraction (LVEF) of
either >=50% by ECHO or greater than institutional lower limit of normal (LLN) by
echocardiogram (ECHO) (while not receiving medications for cardiac function),
corrected QT using Bazett's (QTcB) interval <450 milliseconds (msecs).
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Minimum age
12
Months
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Part 2 ONLY: Previous treatment with dabrafenib, another RAF inhibitor, or a
mitogen-activated protein kinase (MEK) inhibitor (exception: prior treatment with
sorafenib is permitted).
- Malignancy OTHER than the BRAF mutant malignancy under study.
- Had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for nitrosoureas or
mitomycin C) prior to administration of the first dose of study treatment.
- The subject has received an investigational product within the following time period
prior to the first dosing day in the current study: 28 days or 5 half-lives or twice
the duration of the biological effect of the investigational product (whichever is
warranted by the data).
- History of another malignancy. Exception: (a) Subjects who have been successfully
treated and are disease-free for 3 years, (b) a history of completely resected
non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in
stable remission are eligible.
- Current use of a prohibited medication or herbal preparation or requires any of these
medications during the study.
- Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria
for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer
therapy, including major surgery except those that in the opinion of the investigator
are not clinically relevant given the known safety/toxicity profile of dabrafenib
(e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid
based chemotherapy).
- Has leukaemia.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to dabrafenib and its excipients.
- Autologous or allogeneic stem cell transplant within 3 months prior to enrolment
[NOTE: subjects with evidence of active graph versus host disease are excluded].
- History of myocardial infarction, severe or unstable angina, peripheral vascular
disease or familial QTc prolongation.
- Subjects with abnormal cardiac valve morphology (>=grade 2) documented by
echocardiogram (NOTE: subjects with grade 1 abnormalities [i.e., mild
regurgitation/stenosis] can be entered on study).
- Subjects with moderate valvular thickening.
- Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24
weeks
- Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease
or uncontrolled infection), psychological, familial, sociological, or geographical
conditions that do not permit compliance with the protocol; or unwillingness or
inability to follow the procedures required in the protocol.
- Presence of active GI disease or other condition (e.g., small bowel or large bowel
resection) that will interfere significantly with the absorption of drugs.
- Hepatitis B Virus, or Hepatitis C Virus infection (subjects with laboratory evidence
of Hepatitis B Virus clearance may be enrolled).
- Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at
screening or prior to dosing.
- Lactating females who are actively breast feeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/05/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/12/2020
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Sample size
Target
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Accrual to date
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Final
85
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Maryland
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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0
United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Tennessee
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Country [8]
0
0
United States of America
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State/province [8]
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Washington
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Country [9]
0
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Canada
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State/province [9]
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Ontario
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Country [10]
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Denmark
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State/province [10]
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Copenhagen
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Country [11]
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France
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State/province [11]
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Marseille Cedex 5
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Country [12]
0
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France
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State/province [12]
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Paris cedex 05
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Country [13]
0
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France
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State/province [13]
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Paris cedex 12
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Country [14]
0
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France
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State/province [14]
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0
Toulouse cedex 9
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Country [15]
0
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France
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State/province [15]
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Villejuif Cedex
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Country [16]
0
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Germany
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State/province [16]
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Baden-Wuerttemberg
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Country [17]
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Germany
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State/province [17]
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Bayern
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Country [18]
0
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Germany
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Berlin
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Israel
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State/province [19]
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Jerusalem
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Country [20]
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Israel
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State/province [20]
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Ramat-Gan
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Country [21]
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Italy
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State/province [21]
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Milan
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Country [22]
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Spain
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State/province [22]
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Esplugues De Llobregat. Barcelona
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Country [23]
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Spain
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State/province [23]
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Madrid
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Country [24]
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United Kingdom
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State/province [24]
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Surrey
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Country [25]
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United Kingdom
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State/province [25]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent
patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation
study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6
Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and
clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients
participated in only either part 1 or part 2 of the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01677741
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01677741
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