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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.

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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

FieldValue
Enrollment Target 17 participants
Start Date 2009-10
Est. Completion 2013-11
Phase Phase 1

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.