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NCT01609790 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors
A Phase 2 study of Glioblastoma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT01609790: Completed Phase 2 study of Glioblastoma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI).
NCT01609790 is a Phase 2 study of Glioblastoma and Recurrent Glioblastoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 137 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01609790, a Phase 2 study of Glioblastoma and Recurrent Glioblastoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study Summary
This partially randomized phase II trial with a safety run-in component studies the side effects and how well bevacizumab given with or without trebananib works in treating patients with brain tumors that have come back (recurrent). Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and interfere with the ability of tumor cells to grow and spread. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together with trebananib is more effective than bevacizumab alone in treating brain tumors.
Primary Outcome
Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, woun
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
- OTHER Placebo Administration
- OTHER Pharmacological Study
- BIOLOGICAL Trebananib
Study Locations (20)
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Sutter Cancer Research Consortium - Novato
- Saint Joseph Hospital - Orange - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- California Pacific Medical Center-Pacific Campus - San Francisco
- Sutter Solano Medical Center/Cancer Center - Vallejo
Alaska
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Arizona Oncology-Deer Valley Center - Phoenix
- Arizona Oncology Services Foundation - Scottsdale
- Arizona Oncology Associates-West Orange Grove - Tucson
Colorado
- Poudre Valley Hospital - Fort Collins
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2012-06-04 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 2 |
What the finished NCT01609790 record still lists
NCT01609790 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (27% higher).
The record links to 6 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01609790 names 20 study sites across 5 states, led by California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT01609790 about?
NCT01609790 is a clinical study titled "Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors". This partially randomized phase II trial with a safety run-in component studies the side effects and how well bevacizumab given with or without trebananib works in treating patients with brain tumors that have come back (recurrent). Immunotherapy with monoclonal antibodies, such as bevacizumab, may ...
What is the current status of trial NCT01609790?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2012-06-04. Estimated completion is 2022-05-20.
What conditions does trial NCT01609790 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, Gliosarcoma, Oligodendroglioma, Recurrent Brain Neoplasm.
What interventions are being tested in trial NCT01609790?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Placebo Administration (OTHER), Pharmacological Study (OTHER), Trebananib (BIOLOGICAL).
Who is sponsoring clinical trial NCT01609790?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01609790 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01609790's enrollment target sits among peer trials
137 35th of 199 higher than 165 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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