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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

Interventions

Cabozantinib

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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