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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
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
Nagoya University Hospital /ID# 138559
Nagoya, Aichi-ken, Japan
Percentage of participants with adverse events
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hiroshima University Hospital /ID# 139399
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital /ID# 150589
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital /ID# 140433
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital /ID# 149145
Shiwa-gun, Iwate, Japan
Kitasato University Hospital /ID# 148493
Sagamihara-shi, Kanagawa, Japan
Kumamoto University Hospital /ID# 138558
Kumamoto, Kumamoto, Japan
Kyoto Prefect Univ Med /ID# 149093
Kyoto, Kyoto, Japan
Kyoto University Hospital /ID# 163206
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 138464
Sendai, Miyagi, Japan
...and 12 more locations
Objective Response Rate
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).
Time frame: At each visit for approximately 1 year
Overall Survival
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).
Time frame: At each visit for approximately 1 year
Duration of Overall Response
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).
Time frame: At each visit for approximately 1 year