Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
- Conditions
- Malignant GliomaGlioblastoma Multiforme
- Interventions
- Registration Number
- NCT02590263
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm B of Phase 1 portion Whole Brain Radiation ABT-414 administered every other weeks in combination with radiation and temozolomide Arm C of Phase 1 portion Whole Brain Radiation ABT-414 administered every other weeks in combination with radiation and temozolomide Arm C of Phase 1 portion ABT-414 ABT-414 administered every other weeks in combination with radiation and temozolomide Arm B of Phase 1 portion ABT-414 ABT-414 administered every other weeks in combination with radiation and temozolomide Arm A of Phase 1 portion ABT-414 ABT-414 administered every other weeks monotherapy Phase 2 portion ABT-414 ABT-414 administered every other weeks in combination with temozolomide Phase 2 portion Temozolomide ABT-414 administered every other weeks in combination with temozolomide Arm B of Phase 1 portion Temozolomide ABT-414 administered every other weeks in combination with radiation and temozolomide Arm C of Phase 1 portion Temozolomide ABT-414 administered every other weeks in combination with radiation and temozolomide
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC) 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 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 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.
Maximum plasma concentration (Cmax) 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 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 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.
Percentage of participants with adverse events At each visit for approximately 4 years Number of Dose Limiting Toxicities At each visit for approximately 1 year Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.
Progression-free survival At each visit for approximately 1 year 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).
- Secondary Outcome Measures
Name Time Method Objective Response Rate At each visit for approximately 1 year The objective response rate is defined as the proportion of participants with at least one measurable lesion at baseline who achieves a confirmed complete (CR) or partial response (PR) based on RANO criteria (except Arm B and Arm C of Phase 1 portion).
Duration of Overall Response At each visit for approximately 1 year The duration of overall response for a given participant is defined as the number of days from the day the RANO criteria are met for CR or PR (whichever is recorded first) to the date that progressive disease (PD) is objectively documented (based RANO criteria) (except Arm B and Arm C of Phase 1 portion).
Overall Survival At each visit for approximately 1 year Overall survival is defined as number of days from the date of first dose to the date of death for all dosed participants (except Arm B and Arm C of Phase 1 portion).
Trial Locations
- Locations (22)
University of Tsukuba Hospital /ID# 140433
🇯🇵Tsukuba-shi, Ibaraki, Japan
Osaka University Hospital /ID# 140438
🇯🇵Suita-shi, Osaka, Japan
Iwate Medical University Hospital /ID# 149145
🇯🇵Shiwa-gun, Iwate, Japan
Kyorin University Hospital /ID# 140360
🇯🇵Mitaka-shi, Tokyo, Japan
Kitasato University Hospital /ID# 148493
🇯🇵Sagamihara-shi, Kanagawa, Japan
Okayama University Hospital /ID# 148674
🇯🇵Okayama-shi, Okayama, Japan
Kumamoto University Hospital /ID# 138558
🇯🇵Kumamoto-shi, Kumamoto, Japan
Hokkaido University Hospital /ID# 150589
🇯🇵Sapporo-shi, Hokkaido, Japan
Shizuoka Cancer Center /ID# 148673
🇯🇵Sunto-gun, Shizuoka, Japan
Hiroshima University Hospital /ID# 139399
🇯🇵Hiroshima-shi, Hiroshima, Japan
NHO Kyoto Medical Center /ID# 140437
🇯🇵Kyoto, Japan
Nagoya University Hospital /ID# 138559
🇯🇵Nagoya-shi, Aichi, Japan
Kyoto Prefect Univ Med /ID# 149093
🇯🇵Kyoto-shi, Kyoto, Japan
Saitama Medical University International Medical Center /ID# 140361
🇯🇵Hidaka-shi, Saitama, Japan
Kyoto University Hospital /ID# 163206
🇯🇵Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 138464
🇯🇵Sendai-shi, Miyagi, Japan
Nihon University Itabashi Hospital /ID# 149385
🇯🇵Itabashi-ku, Tokyo, Japan
National Cancer Center Hospital /ID# 140435
🇯🇵Chuo-ku, Tokyo, Japan
Dokkyo Medical University Hospital /ID# 150990
🇯🇵Shimotsuga-gun, Tochigi, Japan
Osaka International Cancer Institute /ID# 148494
🇯🇵Osaka, Japan
Tokyo Women's Medical University Hospital /ID# 140436
🇯🇵Shinjuku-ku, Tokyo, Japan
Chiba Cancer Center /ID# 164375
🇯🇵Chiba, Japan