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

NCT00337376 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-01-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Maysa Abu-Khalaf, M.D. · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337376 on ClinicalTrials.gov