CLINICAL TRIALS PROFILE FOR TAK-788
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Clinical Trials for TAK-788
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT02716116 ↗ | A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer | Recruiting | Takeda | Phase 1/Phase 2 | This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. |
NCT02716116 ↗ | A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer | Recruiting | Ariad Pharmaceuticals | Phase 1/Phase 2 | This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. |
NCT02716116 ↗ | A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer | Recruiting | Millennium Pharmaceuticals, Inc. | Phase 1/Phase 2 | This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. |
NCT03482453 ↗ | A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants | Completed | Millennium Pharmaceuticals, Inc. | Phase 1 | The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants. |
NCT03807778 ↗ | A Study of TAK-788 in Japanese Adults With Non-Small Cell Lung Cancer | Active, not recruiting | Takeda | Phase 1 | 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 TAK-788 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 TAK-788. Another aim is to continue checking for side effects from TAK-788. 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 TAK-788 once a day for 28 days. This will count as 1 cycle. Different small groups of participants will receive lower to higher doses of TAK-788. 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 TAK-788 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 TAK-788 worked out from the 1st part of the study. Participants will receive TAK-788 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 TAK-788. The study doctors will also check for side effects from TAK-788. 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 TAK-788 for up to just over 1 year, or longer if their condition stays improved. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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