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Sponsors and Collaborators: |
Yale University Pfizer |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00402415 |
There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from rejecting organ transplants. Sirolimus is being tested for its effects against cancer because it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer growth in these animal models both by direct effects on the tumor cells, and also by blocking production of growth factors that stimulate production of blood vessels. We hope that the combined use of these two drugs will have better anti-cancer effects than either agent alone. This study is designed to find out if different doses of Sirolimus combined with a standard dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by cancer.
Condition | Intervention | Phase |
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Tumors |
Drug: Sunitinib malate Drug: Rapamycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of the Combination of Sirolimus and SU11248 (Sutent(R)) in Patients With Advanced Solid Tumors That Are Non-Curable With Standard Therapy |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Sunitinib malate
C1: 50 mg po days 1-15, 2 weeks off C2: 50 mg po x 4 weeks, 2 weeks off
Drug: Rapamycin
Dose escalation until MTD as follows: C1: not given C2: 4 mg weekly, 8 mg weekly, 12 mg weekly, 20 mg weekly |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Yale Comprehensive Cancer Center at Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Mario Sznol, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Mario Sznol, M.D. Principal Investigator ) |
Study ID Numbers: | 0510000723 |
Study First Received: | November 20, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00402415 |
Health Authority: | United States: Food and Drug Administration |
metastatic malignancy advanced solid tumors unresectable Solid Tumors |
Sirolimus Clotrimazole Sunitinib Miconazole Tioconazole |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents Growth Inhibitors Angiogenesis Modulating Agents |