Description:
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with
glioblastoma multiforme.
Title
- Brief Title: Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
- Official Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
Clinical Trial IDs
- ORG STUDY ID:
M12-356
- SECONDARY ID:
2012-003884-23
- NCT ID:
NCT01800695
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| ABT-414 | Depatuxizumab Mafodotin | Arm A |
| Temozolomide | | Arm A |
Purpose
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with
glioblastoma multiforme.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A | Experimental | ABT-414 in combination with radiation and temozolomide | |
| Arm B | Experimental | ABT-414 in combination with temozolomide | |
| Arm C | Experimental | ABT-414 monotherapy | |
Eligibility Criteria
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
| Maximum Eligible Age: | 99 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number and percentage of participants with adverse events |
| Time Frame: | Every week for an expected average of 34 weeks |
| Safety Issue: | |
| Description: | Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG) |
Secondary Outcome Measures
| Measure: | Biomarker EGFR expression |
| Time Frame: | At screening and post-study |
| Safety Issue: | |
| Description: | Assessment of tumor biomarkers that may correlate with efficacy. |
| Measure: | 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. |
| Safety Issue: | |
| Description: | Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse. |
| Measure: | 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 |
| Safety Issue: | |
| Description: | The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | AbbVie |
Trial Keywords
Last Updated
November 21, 2017
