Last updated on June 2019

A Phase 1 Study of TAK-788 in Japanese Patients

Brief description of study

The purpose of this study is to evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and 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).

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 will look at the safety, efficacy, tolerability and PK of TAK-788 orally administered once daily, and will determine a RP2D.

The study will enroll approximately 28-33 participants. All participants will be asked to take TAK-788, 40 mg starting dose and escalating up to 160 mg until a Maximum Tolerated Dose (MTD) for Japanese patients is determined. An expansion phase may be followed at any dose to further confirm safety observations following identification of MTD/RP2D.

This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 3 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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