Last updated on May 2019

A Study to Evaluate the Safety Tolerability and Pharmacokinetics (PK) of TAK-981 in Adult Participants With Metastatic Solid Tumors or Lymphomas

Brief description of study

The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors or lymphomas.

Detailed Study Description

The drug being tested in this study is called TAK-981. TAK-981 is being tested to evaluate safety, tolerability, and PK in participants who have locally advanced or metastatic solid tumors or relapsed or refractory lymphomas for whom there is no standard therapeutic alternative with established clinical benefit is available. The study will include a dose escalation phase and a dose expansion phase.

The study will enroll approximately 80 participants, approximately 40 to 50 participants in the dose escalation phase and approximately 15 participants in each of the 2 cohorts of dose expansion phase.

In the dose escalation phase, dose levels will be escalated based on safety, and available PK and pharmacodynamic data. This study will also determine the single agent recommended phase 2 dose (RP2D). Participants in dose expansion phase will be enrolled, once maximum tolerated dose (MTD) or biological effective dose (BED) is determined. One of the 2 cohorts in dose expansion phase will consist of participants with relapsed/refractory lymphomas, and other cohort will consist of participants with solid tumors with no standard therapeutic option available with established clinical benefit.

This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 3 years. The overall time to receive treatment in this study is approximately 1 year. Based on decision of sponsor, participants with demonstrated clinical benefit can continue treatment beyond 1 year. Participants will make multiple visits to the clinic, and will make a final visit 30 days after receiving their last dose of drug or before the start of subsequent anticancer therapy, whichever occurs first for a follow-up assessment.

Clinical Study Identifier: NCT03648372

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Fox Chase Cancer Center

Philadelphia, PA United States
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Recruitment Status: Open

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