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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00569946 |
To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Renal Cell |
Drug: AG-013736 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase 2 Study Of AG-013736 As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer |
Estimated Enrollment: | 63 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
AG-013736: Experimental |
Drug: AG-013736
AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID. Number of cycles: until progression or unacceptable toxicity develops.
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Pfizer Investigational Site | |
Fukuoka, Japan | |
Pfizer Investigational Site | |
Kyoto, Japan | |
Pfizer Investigational Site | |
Akita, Japan | |
Pfizer Investigational Site | |
Osaka, Japan | |
Pfizer Investigational Site | |
Tokushima, Japan | |
Pfizer Investigational Site | |
Yamagata, Japan | |
Japan, Chiba | |
Pfizer Investigational Site | |
Kashiwa, Chiba, Japan | |
Japan, Hokkaido | |
Pfizer Investigational Site | |
Sapporo, Hokkaido, Japan | |
Japan, Ibaraki | |
Pfizer Investigational Site | |
Tsukuba, Ibaraki, Japan | |
Japan, Iwate | |
Pfizer Investigational Site | |
Morioka, Iwate, Japan | |
Japan, Kochi-ken | |
Pfizer Investigational Site | |
Nankoku-shi, Kochi-ken, Japan | |
Japan, Osaka | |
Pfizer Investigational Site | |
Osakasayama, Osaka, Japan | |
Japan, Shizuoka | |
Pfizer Investigational Site | |
Sunto-gun, Shizuoka, Japan | |
Pfizer Investigational Site | |
Hamamatsu, Shizuoka, Japan | |
Japan, Tokyo | |
Pfizer Investigational Site | |
Arakawa-ku, Tokyo, Japan | |
Pfizer Investigational Site | |
Chuo-ku, Tokyo, Japan | |
Pfizer Investigational Site | |
Itabashi-ku, Tokyo, Japan |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4061035 |
Study First Received: | December 7, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00569946 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
AG-013736, RCC, Phase 2 |
Urinary Tract Neoplasm Kidney Cancer Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
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 |