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NCT01067066 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01067066: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01067066 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01067066, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.
Primary Outcome
MTD is highest dose level in which 6 patients treated with at most 1 experiencing dose limiting toxicity (DLT). Maximum Tolerated Dose (MTD), measured by clinical and laboratory adverse events.
Interventions
- DRUG Temodar (Temozolomide)
- DRUG TPI 287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-02-03 |
| Est. Completion | 2016-07-06 |
| Phase | Phase 1 |
Why NCT01067066 stopped before completion
NCT01067066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Temodar (Temozolomide) is the first listed.
NCT01067066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01067066 about?
NCT01067066 is a clinical study titled "A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma". The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolo...
What is the current status of trial NCT01067066?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-02-03. Estimated completion is 2016-07-06.
What interventions are being tested in trial NCT01067066?
The interventions under investigation include: Temodar (Temozolomide) (DRUG), TPI 287 (DRUG).
Who is sponsoring clinical trial NCT01067066?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01067066's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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