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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02573324
Registration number
NCT02573324
Ethics application status
Date submitted
28/09/2015
Date registered
9/10/2015
Titles & IDs
Public title
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
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Scientific title
A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
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Secondary ID [1]
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2015-001166-26
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Secondary ID [2]
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M13-813
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Universal Trial Number (UTN)
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Trial acronym
Intellance1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioblastoma
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Gliosarcoma
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Temozolomide
Treatment: Drugs - Depatuxizumab mafodotin
Treatment: Drugs - Placebo for ABT-414
Experimental: Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ) - Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Placebo comparator: Placebo, Radiation and TMZ - Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Experimental: Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ - Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Treatment: Drugs: Temozolomide
Oral Capsule
Treatment: Drugs: Depatuxizumab mafodotin
Intravenous (IV) Infusion
Treatment: Drugs: Placebo for ABT-414
IV Infusion (IV)
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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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Overall Survival (OS)
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Assessment method [1]
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Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [1]
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OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
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Assessment method [1]
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Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Unmethylated MGMT promoter is associated with a worse prognosis in GBM
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Timepoint [1]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [2]
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OS for the MGMT Methylated Group
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Assessment method [2]
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Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
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Timepoint [2]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [3]
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OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
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Assessment method [3]
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Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
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Timepoint [3]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.
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Timepoint [4]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [5]
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PFS for EGFRvIII-Mutated Tumor Subgroup
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Assessment method [5]
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PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.
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Timepoint [5]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [6]
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Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
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Assessment method [6]
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The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (= -1), stable (\> -1 and \< 1), and deteriorated (= 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by = 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
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Timepoint [6]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [7]
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Deterioration Free Survival in MDASI-BT Symptom Interference Score
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Assessment method [7]
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The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (= -1), stable (\> -1 and \< 1), and deteriorated (= 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by = 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
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Timepoint [7]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Secondary outcome [8]
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Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
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Assessment method [8]
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The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.
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Timepoint [8]
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Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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Eligibility
Key inclusion criteria
* Must have a clinical diagnosis of glioblastoma (GBM).
* Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.
* Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
* Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
* Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).
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Minimum age
18
Years
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Maximum age
99
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
* Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
* Prior chemo therapy or radiosensitizer for head and neck cancer.
* Prior radiotherapy to the head or neck in overlap of radiation fields.
* Prior therapy for glioblastoma or other invasive malignancy.
* Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
4/01/2015
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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
4/04/2022
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Sample size
Target
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Accrual to date
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Final
691
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital /ID# 144392 - Liverpool
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Recruitment hospital [2]
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Duplicate_The Prince of Wales Hospital /ID# 144882 - Randwick
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Royal North Shore Hospital /ID# 143870 - St Leonards
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Recruitment hospital [4]
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Calvary Mater Newcastle /ID# 143860 - Waratah
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Recruitment hospital [5]
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Southern Medical Day Care Centre /ID# 143868 - Wollongong
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Princess Alexandra Hospital /ID# 143857 - Woolloongabba
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Recruitment hospital [7]
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Royal Adelaide Hospital /ID# 143867 - Adelaide
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Recruitment hospital [8]
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Calvary North Adelaide Hospita /ID# 143866 - Adelaide
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Recruitment hospital [9]
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St Vincent's Hospital Melbourne /ID# 143858 - Fitzroy Melbourne
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Recruitment hospital [10]
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Duplicate_Austin Hospital /ID# 143859 - Heidelberg
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Recruitment hospital [11]
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St John Of God Subiaco Hospital /ID# 143869 - Subiaco
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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5006 - Adelaide
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Recruitment postcode(s) [9]
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3065 - Fitzroy Melbourne
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment postcode(s) [11]
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6008 - Subiaco
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Recruitment outside Australia
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Petakh Tikva
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Piemonte
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Radiation Therapy Oncology Group
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Summary
Brief summary
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
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Trial website
https://clinicaltrials.gov/study/NCT02573324
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Trial related presentations / publications
Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091. Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202. Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT02573324/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT02573324/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02573324