drugset / Trial / NCT00337376

A Study of the mTOR Inhibitor Rapamycin (Rapamune, Sirolimus) in Combination With Abraxane in Advanced Solid Cancers

NCT00337376

Phase 1 Terminated 23 enrolled Yale University Celgene Corporation · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Rapamycin is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Abraxane is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of metastatic breast cancer, and is a promising drug that is being evaluated in clinical trials for treatment of other cancers. This is a phase I study designed to find out if different doses of Rapamycin, when combined with Abraxane, are safe and well tolerated.

Timeline

Start
2006-02
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 5 mg Oral
Subject Sirolimus Small molecule 10 mg Oral
Subject Sirolimus Small molecule 20 mg Oral
Subject Sirolimus Small molecule 40 mg Oral
Background Paclitaxel Small molecule 100 mg/m2 Intravenous

Indications

No indication recorded.