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Sponsored by: |
AVEO Pharmaceuticals, Inc. |
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Information provided by: | AVEO Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00563147 |
The purpose of this study is to test the safety and tolerability of AV-951 and Torisel™ given in combination for renal cell cancer. The study will also assess the effects of the combination of AV-951 and Torisel™ on the tumor.
AV-951 is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus is an mTOR inhibitor which is approved for the treatment of advanced renal cell carcinoma.
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: AV-951 plus temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1b, Open-Label, Dose-Finding Study to Evaluate the Safety of AV-951 in Combination With Temsirolimus in Subjects With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 36 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
AV-951 plus temsirolimus
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Drug: AV-951 plus temsirolimus
ascending doses of AV-951 capsules administered orally for 21 days with discontinuation for 7 days; ascending doses of temsirolimus administered intravenously every 7 days
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This is a Phase 1b, open-label, dose-finding study of AV-951 in combination with temsirolimus to include approximately 36 subjects with metastatic renal cell carcinoma (mRCC). This study is designed to evaluate the safety, tolerability, dose-limiting toxicities (DLT), maximum tolerated dose (MTD), pharmacokinetic, pharmacogenomic, and antineoplastic activity of AV-951 when administered in combination with temsirolimus. AV-951 will be administered once daily for 3 weeks beginning on Day 1 of Cycle 1, followed by 1 week off (1 cycle = 4 weeks). Temsirolimus will be administered intravenously once weekly starting on Day 8 of Cycle 1.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following hematologic abnormalities:
Any of the following serum chemistry abnormalities:
Significant cardiovascular disease, including:
Prohibited medications:
Systemic hormonal therapy within 4 weeks prior to and during study, with the exception of:
Radiotherapy:
United States, California | |
UCLA Jonsson Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Nazy Zomordian, MSN, CUNP 310-794-7704 NZomorodian@mednet.ucla.edu | |
Principal Investigator: Fairooz F Kabbinavar, M.D. | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Denise Haas 650-736-1252 | |
Contact dhaas@stanford.edu | |
Principal Investigator: Sandhya Srinivas, MD | |
United States, Florida | |
H. Lee Moffitt Cancer Center | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Leticia Tetteh, RN, BSN 813-903-4617 Leticia.Tetteh@moffitt.org | |
Principal Investigator: Mayer Fishman, M.D., PhD | |
United States, Nebraska | |
Nebraska Methodist Hospital | Recruiting |
Omaha, Nebraska, United States, 68114 | |
Contact: Gladys Pierce 402-354-5129 gladys.pierce@nmhs.org | |
Principal Investigator: Ralph Hauke, MD | |
United States, Texas | |
The Methodist Hospital Research Institute | Completed |
Houston, Texas, United States, 77030 |
Study Director: | Pankaj Bhargava, M.D. | AVEO Pharmaceuticals |
Responsible Party: | AVEO Pharmaceuticals ( Margaret Taleff Senior Director, Regulatory Affairs ) |
Study ID Numbers: | AV-951-07-102 |
Study First Received: | November 21, 2007 |
Last Updated: | February 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00563147 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Carcinoma Signs and Symptoms Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |