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Brief Title: A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer
Official Title: A Phase 1/2 Study of the Oral EGFR/HER2 Inhibitor TAK-788 in Japanese Non-Small Cell Lung Cancer Patients
Study ID: NCT03807778
Brief Summary: This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of the study. The main aim of the 1st part of the study is to check how much Mobocertinib adults with non-small cell lung cancer (NSCLC) can receive without getting side effects from it. The main aim of the 2nd part of the study is to learn if the condition of adults with non-small cell lung cancer improves after treatment with Mobocertinib. Another aim is to continue checking for side effects from Mobocertinib. In the 1st part of the study, at the first visit, the study doctor will check who can take part. For those that can take part, participants will take a capsule of Mobocertinib once a day for 28 days. This will count as 1 cycle. Different small groups of participants will receive lower to higher doses of Mobocertinib. The study doctors will check for side effects after each dose of TAK 788. In this way, researchers can work out the best dose of Mobocertinib to give participants in the 2nd part of the study. Participants will visit the clinic 30 days after their treatment has finished for a final check-up. In the 2nd part of the study, at the first visit, the study doctor will check who can take part. Participants will receive the best dose of Mobocertinib worked out from the 1st part of the study. Participants will receive Mobocertinib in the same way as those from the 1st part of the study. The study doctors will learn if the condition of these participants improves after treatment with Mobocertinib. The study doctors will also check for side effects from Mobocertinib. After treatment has finished, participants will visit the clinic every 12 weeks until the end of the study. In both parts of the study, participants can receive Mobocertinib for up to just over 1 year, or longer if their condition stays improved.
Detailed Description: The drug being tested in this study is called Mobocertinib. Mobocertinib is being tested to treat Japanese participants with NSCLC. This study has two parts (Phase 1 part and Phase 2 part), Phase 1 part of this study will look at the safety, efficacy, tolerability and PK of Mobocertinib orally administered once daily, and will determine a RP2D. Phase 2 study will look at the efficacy and safety of Mobocertinib in treatment naive Japanese NSCLC patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation. All participants will be assigned to Phase 1 part or Phase 2 part and will be asked to take Mobocertinib capsule as following dosage and regimen; Phase 1 part; Mobocertinib, 40 mg as starting dose, once daily, and escalating up to 160 mg until a Maximum Tolerated Dose (MTD). An expansion phase may be followed at any dose to further confirm safety observations following identification of MTD/RP2D. Phase 2 part; Mobocertinib, 160 mg, once daily The study will enroll approximately 58-63 participants (Phase 1 part; 28-33 and Phase 2 part; 30). This multi-center trial will be conducted in Japan. The overall time to participate in this study of Phase 1 part is approximately 3 years and Phase 2 part is approximately 4 years. Participants will make multiple visits to the clinic in the treatment period, and the post-treatment period including follow-up assessments after the last dose of the study drug.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
Fujita Health University Hospital, Toyoake, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Hyogo Cancer Cente, Akashi, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Okayama University Hospital, Kita-ku, Okayama, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan
Saitama Cancer Center, Ina, Saitama, 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
Yamaguchi Ube Medical Center, Ube, Yamaguchi, Japan
Kyushu University Hospital, Fukuoka, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kyoto University Hospital, Kyoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Tokushima University Hospital, Tokushima, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR