Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma (NCT02590263) | Clinical Trial Compass
CompletedPhase 1/2
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Japan53 participantsStarted 2015-08-24
Plain-language 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.
Who can participate
Age range
20 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Japanese participants with WHO grade III or IV malignant glioma
* 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion
* 80 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with adverse events
Timeframe: At each visit for approximately 4 years
2
Number of Dose Limiting Toxicities
Timeframe: At each visit for approximately 1 year
3
Progression-free survival
Timeframe: At each visit for approximately 1 year
4
Area under the plasma concentration-time curve (AUC) of ABT-414
Timeframe: 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
5
Maximum plasma concentration (Cmax) of ABT-414
Timeframe: 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