Spots Global Cancer Trial Database for Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
Official Title: A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT03410108
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate efficacy and safety of brigatinib in Japanese participants with anaplastic lymphoma kinase (ALK)-positive NSCLC.
Detailed Description: The drug being tested in this study is called brigatinib. Brigatinib is being tested in participants with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese participants with ALK-positive NSCLC. The study will enroll approximately 110 participants. Participants will be enrolled in non-randomized and opened manner: - Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle. All participants will be asked to take tablets of brigatinib once daily with or without food throughout the study. This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 53 months. Participants will make multiple visits to the clinic during the 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
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
Nagoya University Hospital, Nagoya, Aichi, Japan
Fujita Health University Hospital, Toyoake, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Matsuzaka Citizen's Hospital, Matsuzaka, Mie, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Kurashiki Central Hospital, Kurashiki, Okayama, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Saitama Cancer Center, Ina, Saitama, Japan
Shizuoka Cancer Center, Nagaizumi-cho, Shizuoka, Japan
Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan
Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Cancer Institute Hospital, Koto-ku, Tokyo, Japan
Chiba University Hospital, Chiba, , Japan
Kyushu University Hospital, Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Kyoto University Hospital, Kyoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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