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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 is a Phase 1 study that was terminated before completion, run by New Mexico Cancer Research Alliance. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00996346
The ClinicalTrials.gov registry entry for NCT00996346 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Mexico Cancer Research Alliance, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Irinotecan&Temsirolimus:Arm1, Level 1 is the first listed.
NCT00996346 reports 0 study locations.
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.
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