ANG1005 in Patients With Recurrent High-Grade Glioma
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Angiochem Inc
- Study ID
- NCT01967810
- Phase
- PHASE2
- Status
- Completed
Conditions
- Brain Tumor, Recurrent
- Glioblastoma
- Glioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ANG1005 — DRUGANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
- Bevacizumab — DRUGFor participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
Study Details
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
Key Dates
- First listed
- Oct 23, 2013
- Start date
- Oct 31, 2013
- Status verified
- Feb 2020
- Primary completion
- Feb 29, 2016
- Completion
- Sep 30, 2017
Study Design
- Enrollment
- 73 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1ANG1005 administered to bevacizumab-naive recurrent GBM participants
- Experimental: Arm 2ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
- Experimental: Arm 3ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants
Primary Outcome Measure
Objective Response Rate (ORR) (Arms 1 and 3) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moores UC San Diego Cancer Center | La Jolla | California | 92093-0698 | - |
| Northwestern University | Chicago | Illinois | 60611 | - |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | - |
| Cleveland Clinic | Cleveland | Ohio | 44195 | - |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15323 | - |
| Univeristy of Texas Health Science Center in San Antonio | San Antonio | Texas | 78229 | - |
| Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22903 | - |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | - |
| University of Washington Medical Center | Seattle | Washington | 98195 | - |
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