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Spots Global Cancer Trial Database for Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

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Trial Identification

Brief Title: Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Official Title: A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA

Study ID: NCT03128411

Interventions

Bosutinib

Study Description

Brief Summary: Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

Detailed Description: The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Fujita Health University Hospital, Toyoake-City, Aichi, Japan

Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan

Akita University Hospital, Akita City, Akita, Japan

Japanese Red Cross Narita Hospital, Narita, Chiba, Japan

Ehime University Hospital, Toon-shi, Ehime, Japan

Kobe City Medical Center General Hospital, Kobe-city, Hyogo, Japan

Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan

Yokohama City University Medical Center, Yokohama, Kanagawa, Japan

National Hospital Organization Osaka Minami Medical Center, Kawachinagano, Osaka, Japan

Osaka City University Hospital, Osaka-City, Osaka, Japan

Kindai University Hospital, Osaka-Sayama, Osaka, Japan

Hamamatsu University Hospital, Hamamatsu, Shizuoka, Japan

Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan

NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, Japan

National Hospital Organization Disaster Medical Center, Tachikawa, Tokyo, Japan

Yamagata University Hospital, Yamagata-Shi, Yamagata, Japan

Chiba University Hospital, Chiba, , Japan

National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan

Saga University Hospital, Saga, , Japan

Nippon Medical School Hospital, Tokyo, , Japan

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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