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NCT00996346 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
A Phase 1 study, sponsored by New Mexico Cancer Research Alliance.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00996346: Clinical Trial Phase 1 study, sponsored by New Mexico Cancer Research Alliance.
NCT00996346 is a Phase 1 study that was terminated before completion, run by New Mexico Cancer Research Alliance. 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
NCT00996346, a Phase 1 study, was terminated before completion, sponsored by New Mexico Cancer Research Alliance.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Refractory soft tissue sarcoma remains a difficult malignancy to treat. The mammalian target of rapamycin (mTOR) is an enzyme that plays an important role in cancer cell survival. mTOR inhibitors, like temsirolimus, have shown activity in sarcoma. Irinotecan is a chemotherapy drug that has also been used to treat sarcoma. However, it is unknown whether combining these two drugs would result in improved efficacy with acceptable toxicity. Therefore, the goal of this phase I study is to determine the maximum tolerated dose (MTD) and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis to refractory soft tissue sarcoma patients.
Primary Outcome
The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy
Interventions
- DRUG Irinotecan&Temsirolimus:Arm1, Level 1
- DRUG Irinotecan&Temsirolimus:Arm 1, Level 2
- DRUG Irinotecan&Temsirolimus:Arm 2, Level 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
Why NCT00996346 stopped before completion
NCT00996346 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 3 interventions - of which Irinotecan&Temsirolimus:Arm1, Level 1 is the first listed.
NCT00996346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996346 about?
NCT00996346 is a clinical study titled "Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas". Refractory soft tissue sarcoma remains a difficult malignancy to treat. The mammalian target of rapamycin (mTOR) is an enzyme that plays an important role in cancer cell survival. mTOR inhibitors, like temsirolimus, have shown activity in sarcoma. Irinotecan is a chemotherapy drug that has also been...
What is the current status of trial NCT00996346?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2009-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00996346?
The interventions under investigation include: Irinotecan&Temsirolimus:Arm1, Level 1 (DRUG), Irinotecan&Temsirolimus:Arm 1, Level 2 (DRUG), Irinotecan&Temsirolimus:Arm 2, Level 1 (DRUG).
Who is sponsoring clinical trial NCT00996346?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00996346'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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