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NCT01648348 · ClinicalTrials.gov registry record · Phase 1
Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT01648348: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01648348 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648348, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.
Primary Outcome
MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of DLT's will be reported here.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
- OTHER Pharmacological Study
- BIOLOGICAL Anti-Endoglin Chimeric Monoclonal Antibody TRC105
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2012-11 |
| Est. Completion | 2017-04-15 |
| Phase | Phase 1 |
What the finished NCT01648348 record still lists
NCT01648348 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01648348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648348 about?
NCT01648348 is a clinical study titled "Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme". This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as an...
What is the current status of trial NCT01648348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2012-11. Estimated completion is 2017-04-15.
What interventions are being tested in trial NCT01648348?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Pharmacological Study (OTHER), Anti-Endoglin Chimeric Monoclonal Antibody TRC105 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01648348?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01648348's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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