Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma
1 other identifier
interventional
53
1 country
22
Brief Summary
This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2015
Longer than P75 for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2015
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2020
CompletedSeptember 3, 2020
September 1, 2020
5 years
September 28, 2015
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Percentage of participants with adverse events
At each visit for approximately 4 years
Number of Dose Limiting Toxicities
Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.
At each visit for approximately 1 year
Progression-free survival
Time to progression-free survival is defined as the number of days from the date of first dose 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 (except Arm B and Arm C of Phase 1 portion).
At each visit for approximately 1 year
Area under the plasma concentration-time curve (AUC) of ABT-414
Assessed during the Phase 1 portion of the study, the area under the plasma concentration-time curve (AUC) is a method of measurement to determine the total exposure of a drug in blood plasma.
Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects
Maximum plasma concentration (Cmax) of ABT-414
Assessed during the Phase 1 portion of the study, the maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects
Secondary Outcomes (3)
Objective Response Rate
At each visit for approximately 1 year
Overall Survival
At each visit for approximately 1 year
Duration of Overall Response
At each visit for approximately 1 year
Study Arms (4)
Arm A of Phase 1 portion
EXPERIMENTALABT-414 administered every other weeks monotherapy
Phase 2 portion
EXPERIMENTALABT-414 administered every other weeks in combination with temozolomide
Arm C of Phase 1 portion
EXPERIMENTALABT-414 administered every other weeks in combination with radiation and temozolomide
Arm B of Phase 1 portion
EXPERIMENTALABT-414 administered every other weeks in combination with radiation and temozolomide
Interventions
Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
Temozolomide will be administered per label.
ABT-414 will be administered by intravenous infusion
Eligibility Criteria
You may qualify if:
- Japanese participants with WHO grade III or IV malignant glioma
- or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion
- or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion
- Adequate bone marrow function
- Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion
- Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1 portion
- Participants must have confirmed EGFR amplification by central lab in Phase 2 portion
You may not qualify if:
- Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion)
- Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion
- Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion
- Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (22)
Nagoya University Hospital /ID# 138559
Nagoya, Aichi-ken, 466-8560, Japan
Hiroshima University Hospital /ID# 139399
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido University Hospital /ID# 150589
Sapporo, Hokkaido, 060-8648, Japan
University of Tsukuba Hospital /ID# 140433
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital /ID# 149145
Shiwa-gun, Iwate, 028-3695, Japan
Kitasato University Hospital /ID# 148493
Sagamihara-shi, Kanagawa, 252-0375, Japan
Kumamoto University Hospital /ID# 138558
Kumamoto, Kumamoto, 860-8556, Japan
Kyoto Prefect Univ Med /ID# 149093
Kyoto, Kyoto, 602-8566, Japan
Kyoto University Hospital /ID# 163206
Kyoto, Kyoto, 606-8507, Japan
Tohoku University Hospital /ID# 138464
Sendai, Miyagi, 980-8574, Japan
Okayama University Hospital /ID# 148674
Okayama, Okayama-ken, 700-8558, Japan
Osaka University Hospital /ID# 140438
Suita-shi, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center /ID# 140361
Hidaka-shi, Saitama, 350-1298, Japan
Shizuoka Cancer Center /ID# 148673
Sunto-gun, Shizuoka, 411-8777, Japan
Dokkyo Medical University Hospital /ID# 150990
Shimotsuga-gun, Tochigi, 321-0293, Japan
National Cancer Center Hospital /ID# 140435
Chuo-ku, Tokyo, 104-0045, Japan
Nihon University Itabashi Hospital /ID# 149385
Itabashi-ku, Tokyo, 173-0032, Japan
Kyorin University Hospital /ID# 140360
Mitaka-shi, Tokyo, 181-8611, Japan
Tokyo Women's Medical University Hospital /ID# 140436
Shinjuku-ku, Tokyo, 162-8666, Japan
Chiba Cancer Center /ID# 164375
Chiba, 260-0801, Japan
NHO Kyoto Medical Center /ID# 140437
Kyoto, 612-0861, Japan
Osaka International Cancer Institute /ID# 148494
Osaka, 541-8567, Japan
Related Publications (1)
Narita Y, Muragaki Y, Kagawa N, Asai K, Nagane M, Matsuda M, Ueki K, Kuroda J, Date I, Kobayashi H, Kumabe T, Beppu T, Kanamori M, Kasai S, Nishimura Y, Xiong H, Ocampo C, Yamada M, Mishima K. Safety and efficacy of depatuxizumab mafodotin in Japanese patients with malignant glioma: A nonrandomized, phase 1/2 trial. Cancer Sci. 2021 Dec;112(12):5020-5033. doi: 10.1111/cas.15153. Epub 2021 Oct 30.
PMID: 34609773DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
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
September 28, 2015
First Posted
October 29, 2015
Study Start
August 24, 2015
Primary Completion
August 27, 2020
Study Completion
August 27, 2020
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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 and 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.