NCT00337376

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

A Phase I Study of the mTOR Inhibitor Rapamycin (Rapamune, Sirolimus) in Combination With Abraxane (Paclitaxel Protein-bound Particles) in Advanced Solid Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Cancers

Interventions

Type	Name	Description
DRUG	Rapamune	Dose escalation as follows: 5mg PO, 10mg PO, 20mg PO, 40mg PO
DRUG	Abraxane	intravenous administration of 100mg/m2 Abraxane over 30 minutes, weekly for three out of four consecutive weeks.

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2006-06-15
• Last updated: 2014-01-14

Locations

1 site across 1 country: United States