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

Official Title

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

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.

Trial Description

Primary Outcome:

  • Dose Escalation Phase: Maximum Tolerated Dose (MTD) of TAK-659
  • Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of TAK-659
Secondary Outcome:
  • Dose Escalation Phase: Cmax: Maximum Observed Plasma Concentration for TAK-659
  • Dose Escalation Phase: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-659
  • Dose Escalation Phase : AUCtau: Area Under the Plasma Concentration-time Curve During Dosing Interval
  • Overall Response Rate (ORR)
  • Duration of Response (DOR)
  • Time to Progression (TTP)
  • Safety Expansion Phase: Progression-free Survival (PFS)
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 FL or MZL will be added to Cohort B, in the safety expansion phase. This multi-centre 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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