Overview

This trial is active, not recruiting.

Condition glioblastoma multiforme
Treatments abt-414, temozolomide, whole brain radiation
Phase phase 1
Sponsor AbbVie
Start date April 2013
End date January 2017
Trial size 196 participants
Trial identifier NCT01800695, 2012-003884-23, M12-356

Summary

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-414 in combination with radiation and temozolomide
abt-414
ABT-414 will be administered by intravenous infusion
temozolomide
Temozolomide will be administered per label and local prescribing regulations.
whole brain radiation
Whole Brain radiation will be administered in 30 fractions.
(Experimental)
ABT-414 in combination with temozolomide
abt-414
ABT-414 will be administered by intravenous infusion
temozolomide
Temozolomide will be administered per label and local prescribing regulations.
(Experimental)
ABT-414 monotherapy
abt-414
ABT-414 will be administered by intravenous infusion

Primary Outcomes

Measure
Number and percentage of participants with adverse events
time frame: Every week for an expected average of 34 weeks
Maximum concentration of ABT-414
time frame: 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
time frame: Every week for an expected average of 34 weeks
Minimum Concentration of ABT-414
time frame: 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
time frame: 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

Measure
Biomarker EGFR expression
time frame: At screening and post-study
Progression Free Survival
time frame: 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
time frame: 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

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: 1. Glioblastoma Multiforme (GBM) 2. 70 or above on Karnofsky Performance Status 3. Adequate bone marrow function 4. Recurrent GBM per RANO criteria 5. Subjects must have confirmed EGFR amplification by central lab Exclusion Criteria: 1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM 2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM 3. Allergies to temozolomide, dacarbazine, IgG containing agents 4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed 5. Subjects that have had more than one disease recurrence

Additional Information

Official title A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.
Location data was received from the National Cancer Institute and was last updated in July 2016.