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NCT01989052 · ClinicalTrials.gov registry record · Phase 1
Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma
A Phase 1 study, sponsored by Annick Desjardins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01989052: Clinical Trial Phase 1 study, sponsored by Annick Desjardins.
NCT01989052 is a Phase 1 study that was terminated before completion, run by Annick Desjardins. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989052, a Phase 1 study, was terminated before completion, sponsored by Annick Desjardins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. The Primary Objectives are: * Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with lomustine among patients with recurrent malignant glioma (World Health Organization (WHO) grade III or IV) who have not been previously treated with bevacizumab. * Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant gliomas that have not been previously treated with bevacizumab based upon 6-month progression free survival (PFS6). Note: 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 lomustine 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 lomustine. Subjects will be administered CTO orally on a continuous daily dosing schedule, while subjects will receive oral lomustine (110 mg/m2) every 6 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). MTD is defined as the highest dose level at which ≤ 1 o
Interventions
- DRUG Lomustine
- DRUG CTO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
Why NCT01989052 stopped before completion
NCT01989052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Lomustine is the first listed.
NCT01989052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989052 about?
NCT01989052 is a clinical study titled "Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma". This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. The Primary Objectives are: * Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined wit...
What is the current status of trial NCT01989052?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2014-05. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01989052?
The interventions under investigation include: Lomustine (DRUG), CTO (DRUG).
Who is sponsoring clinical trial NCT01989052?
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 NCT01989052's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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