NCT03359733

A Study to Evaluate the Effect of Food on the Pharmacokinetics (PK) of TAK-659 in Participants With Advanced Solid Tumor

An Open-Label, Phase 1, Two-Way, Crossover Study of the Effect of Food on the Pharmacokinetics of TAK-659 in Patients With Advanced Solid Tumor and/or Lymphoma Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the effect of food on the single-dose PK of TAK-659 in participants with advanced solid tumors and/or lymphomas.

Detailed description

The drug being tested in this study is called TAK-659. TAK-659 is being tested in participants with advanced solid tumors and/or lymphomas in order to determine the effect of food on the PK of single oral dose of TAK-659 tablet formulation. The study will enroll approximately 20 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as: * TAK-659 100 mg Fasted + TAK-659 100 mg Fed * TAK-659 100 mg Fed + TAK-659 100 mg Fasted All participants will be asked to take single oral dose of TAK-659 tablet on Day 1 and Day 8 of a 15-day food effect treatment period. Upon completion of the food effect treatment period, participants can continue in the optional post food effect treatment period to receive TAK-659 100 mg, once daily in a 28-day treatment cycle until disease progression, unacceptable toxicity, or the start of another anticancer therapy upon request by the investigator and agreement by the project clinician. This single or multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 58 weeks. Participants will visit the clinic on Day -1 and remain confined until Day 15 of food effect treatment period. Participants will make a visit to the clinic after 28 days after last dose of study drug for a follow-up assessment.

Conditions

• Lymphoma, Malignant
• Advanced Solid Neoplasms

Interventions

Type	Name	Description
DRUG	TAK-659	TAK-659 tablet.

Timeline

• Start date: 2018-02-28
• Primary completion: 2019-01-14
• Completion: 2019-08-20
• First posted: 2017-12-02
• Last updated: 2023-02-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study