NCT02954406

A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma

A Phase 1b, Dose Escalation Study to Determine the Recommended Phase 2 Dose of TAK-659 in Combination With Bendamustine (±Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Patients With Advanced Non-Hodgkin Lymphoma After At Least 1 Prior Line of Therapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of TAK-659 when administered in combination with bendamustine, bendamustine + rituximab, gemcitabine, lenalidomide, or ibrutinib.

Detailed description

The drug being tested in this study is called TAK-659. TAK-659 is being tested to treat people who have advanced non-Hodgkin lymphoma. This study will determine the MTD or RP2D for TAK-659 in combination with bendamustine, bendamustine + rituximab, gemcitabine, lenalidomide, and ibrutinib. The study will enroll approximately 96 participants. Participants will be assigned to one of the 5 combination cohorts: * Dose Escalation Phase Cohort A: TAK-659 + Bendamustine * Dose Escalation Phase Cohort B: TAK-659 + Bendamustine + Rituximab * Dose Escalation Phase Cohort C: TAK-659 + Gemcitabine * Dose Escalation Phase Cohort D: TAK-659 + Lenalidomide * Dose Escalation Phase Cohort E: TAK-659 + Ibrutinib This study comprises 2 phases: a dose escalation phase and a safety expansion phase. Participants in all 5 cohorts (Cohorts A-E) will participate in the dose escalation phase of the study. Approximately 12 additional participants with advanced follicular lymphoma (FL) or marginal zone lymphoma (MZL) will be added to Cohort B, in the safety expansion phase. This multi-center trial will be conducted in North America and Europe. The overall time to participate in this study is approximately 30 months. Participants will make multiple visits to the clinic and will be followed up for safety for 28 days after the last dose of study drug.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	TAK-659	TAK-659 immediate release tablet
DRUG	Bendamustine	Bendamustine intravenous infusion
DRUG	Rituximab	Rituximab intravenous infusion
DRUG	Gemcitabine	Gemcitabine intravenous infusion
DRUG	Lenalidomide	Lenalidomide capsule
DRUG	Ibrutinib	Ibrutinib capsule

Timeline

• Start date: 2017-03-05
• Primary completion: 2020-07-27
• Completion: 2020-07-27
• First posted: 2016-11-03
• Last updated: 2022-02-18
• Results posted: 2022-02-18

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study