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Sponsors and Collaborators: |
Yale University Abraxis BioScience Inc. |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00337376 |
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.
Condition | Intervention | Phase |
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Advanced Solid Cancers |
Drug: Rapamune Drug: Abraxane |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of the mTOR Inhibitor Rapamycin (Rapamune, Sirolimus) in Combination With Abraxane (Paclitaxel Protein-Bound Particles) in Advanced Solid Cancers |
Estimated Enrollment: | 24 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hemoglobin ≥ 9 g/dL leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)2.5 X institutional upper limit of normal creatinine within 1.5 x ULN OR creatinine clearance ≥50 mL/min/1.73 m² for patients with creatinine levels ≥1.5 ULN.
Exclusion Criteria:
Contact: Jeannie Kluytenaar, RN | 203-785-6523 | Jeannie.kluytenaar@yale.edu |
Contact: Michele Alguard | 203-737-5908 | michele.alguard@yale.edu |
United States, Connecticut | |
Yale Comprehensive Cancer Center at Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Maysa Abu-Khalaf, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Maysa Abu-Khalaf, M.D. Principal Investigator ) |
Study ID Numbers: | 0511000860 |
Study First Received: | June 13, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00337376 |
Health Authority: | United States: Institutional Review Board |
Sirolimus Clotrimazole Paclitaxel Miconazole Tioconazole |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents Tubulin Modulators Antineoplastic Agents, Phytogenic |