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NCT01189240 · ClinicalTrials.gov registry record · Phase 1
RO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01189240: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01189240 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01189240, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and the best dose of RO4929097 to see how well it works when given together with bevacizumab compared to bevacizumab alone in treating patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving RO4929097 together with bevacizumab may kill more tumor cells.
Primary Outcome
Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- BIOLOGICAL bevacizumab
- DRUG gamma-secretase/Notch signalling pathway inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
Why NCT01189240 stopped before completion
NCT01189240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01189240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01189240 about?
NCT01189240 is a clinical study titled "RO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma". This phase I/II trial is studying the side effects and the best dose of RO4929097 to see how well it works when given together with bevacizumab compared to bevacizumab alone in treating patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of tumor cells by blocking ...
What is the current status of trial NCT01189240?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-12. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01189240?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), bevacizumab (BIOLOGICAL), gamma-secretase/Notch signalling pathway inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01189240?
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 NCT01189240's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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