Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
2 other identifiers
interventional
202
0 countries
N/A
Brief Summary
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2013
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 28, 2013
CompletedStudy Start
First participant enrolled
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2017
CompletedNovember 21, 2017
July 1, 2017
4.2 years
February 5, 2013
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number and percentage of participants with adverse events
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Every week for an expected average of 34 weeks
Maximum concentration of ABT-414
Measurement of the maximum concentration of ABT- 414 in the blood
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Number of Dose Limiting Toxicities
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Every week for an expected average of 34 weeks
Minimum Concentration of ABT-414
Measurement of the minimum concentration of ABT-414 in the blood
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Half-life of ABT-414
Measurement of the clearance of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Secondary Outcomes (3)
Biomarker EGFR expression
At screening and post-study
Progression Free Survival
Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.
Overall Survival
Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination
Study Arms (3)
Arm A
EXPERIMENTALABT-414 in combination with radiation and temozolomide
Arm B
EXPERIMENTALABT-414 in combination with temozolomide
Arm C
EXPERIMENTALABT-414 monotherapy
Interventions
ABT-414 will be administered by intravenous infusion
Temozolomide will be administered per label and local prescribing regulations.
Eligibility Criteria
You may qualify if:
- Glioblastoma Multiforme (GBM)
- or above on Karnofsky Performance Status
- Adequate bone marrow function
- Recurrent GBM per RANO criteria
- Subjects must have confirmed EGFR amplification by central lab
You may not qualify if:
- For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
- For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
- Allergies to temozolomide, dacarbazine, IgG containing agents
- Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
- Subjects that have had more than one disease recurrence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (3)
Lassman AB, Roberts-Rapp L, Sokolova I, Song M, Pestova E, Kular R, Mullen C, Zha Z, Lu X, Gomez E, Bhathena A, Maag D, Kumthekar P, Gan HK, Scott AM, Guseva M, Holen KD, Ansell PJ, van den Bent MJ. Comparison of Biomarker Assays for EGFR: Implications for Precision Medicine in Patients with Glioblastoma. Clin Cancer Res. 2019 Jun 1;25(11):3259-3265. doi: 10.1158/1078-0432.CCR-18-3034. Epub 2019 Feb 22.
PMID: 30796037DERIVEDLassman 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.
PMID: 29982805DERIVEDGoss GD, Vokes EE, Gordon MS, Gandhi L, Papadopoulos KP, Rasco DW, Fischer JS, Chu KL, Ames WW, Mittapalli RK, Lee HJ, Zeng J, Roberts-Rapp LA, Loberg LI, Ansell PJ, Reilly EB, Ocampo CJ, Holen KD, Tolcher AW. Efficacy and safety results of depatuxizumab mafodotin (ABT-414) in patients with advanced solid tumors likely to overexpress epidermal growth factor receptor. Cancer. 2018 May 15;124(10):2174-2183. doi: 10.1002/cncr.31304. Epub 2018 Mar 13.
PMID: 29533458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Earle Bain, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 28, 2013
Study Start
April 2, 2013
Primary Completion
June 19, 2017
Study Completion
June 19, 2017
Last Updated
November 21, 2017
Record last verified: 2017-07