⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

Mobocertinib

Study Description

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.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Study Director

Affiliation: Takeda

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: