Last updated on May 2020

A Phase 1/2 Study of TAK-788 in Japanese Patients


Brief description of study

The purpose of this study is to evaluate the safety, efficacy, tolerability and pharmacokinetics (PK) of TAK-788. At first, Phase 1 part of this study is designed to determine a recommended phase 2 dose (RP2D) of TAK-788 in Japanese participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). After phase 1 study, the phase 2 part of this study will be conducted to evaluate the efficacy and safety of TAK-788 in treatment naive Japanese NSCLC patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation.

Detailed Study Description

The drug being tested in this study is called TAK-788. TAK-788 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 TAK-788 orally administered once daily, and will determine a RP2D. Phase 2 study will look at the efficacy and safety of TAK-788 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 TAK-788 capsule as following dosage and regimen;

Phase 1 part; TAK-788, 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; TAK-788, 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.

Clinical Study Identifier: NCT03807778

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