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NCT01954030 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 CTO + Bevacizumab for Recurrent Glioma Post-Bevacizumab Failure
A Phase 1 study, sponsored by Annick Desjardins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01954030: Clinical Trial Phase 1 study, sponsored by Annick Desjardins.
NCT01954030 is a Phase 1 study that was terminated before completion, run by Annick Desjardins. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954030, a Phase 1 study, was terminated before completion, sponsored by Annick Desjardins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary objectives of the study are to determine the maximum tolerated dose (MTD) of Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2). This study was terminated early due to funding issues. At the time of termination, the study was still in Phase 1 and no MTD for the combination of CTO and bevacizumab had been determined for this population. Phase 2 will not proceed.
Primary Outcome
A standard "3+3" design to determine the MTD of CTO in combination with bevacizumab. Subjects will be administered CTO orally on a continuous daily dosing schedule, while subjects will receive bevacizumab (10 mg/kg) every 2 weeks. Cohorts of 3-6 subjects will accrue at each dose level of CTO, beginning with 225 mg/m2, until MTD is defined. The MTD is the highest dose level at which ≤ 1 out of 6 experienced a dose limiting toxicity (DLT).
Interventions
- DRUG CTO and Bevacizumab
- DRUG CTO alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
Why NCT01954030 stopped before completion
NCT01954030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which CTO and Bevacizumab is the first listed.
NCT01954030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954030 about?
NCT01954030 is a clinical study titled "Phase 1/2 CTO + Bevacizumab for Recurrent Glioma Post-Bevacizumab Failure". The primary objectives of the study are to determine the maximum tolerated dose (MTD) of Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed bevacizumab (Phase 1); to det...
What is the current status of trial NCT01954030?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-10. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01954030?
The interventions under investigation include: CTO and Bevacizumab (DRUG), CTO alone (DRUG).
Who is sponsoring clinical trial NCT01954030?
This trial is sponsored by Annick Desjardins, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01954030's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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