Spots Global Cancer Trial Database for A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma
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Trial Identification
Brief Title: A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma
Official Title: A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy
Study ID: NCT03339219
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.
Detailed Description: The drug being tested in this study is called cabozantinib. Cabozantinib is being tested to treat people who have advanced renal cell carcinoma. This study will look at the efficacy of cabozantinib. The study will enroll approximately 35 patients. Participants will be enrolled in one treatment group in non-randomized and opened manner: • Cabozantinib 60 mg All participants will be asked to take tablets of cabozantinib at once daily in the fasted state throughout the study. This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately at most 3 years. Participants will make multiple visits to the clinic in treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Nagoya University Hospital, Nagoya, Aichi, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Nippon Medcal School Hospital, Bunkyo-ku, Tokyo, Japan
Toranomon Hospital, Minato-ku, Tokyo, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo, Japan
Kyushu University Hospital, Fukuoka, , Japan
Niigata University Medical and Dental Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka City University Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Tokushima University Hospital, Tokushima, , Japan
Yamagata University Hospital, Yamagata, , Japan
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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