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:

  • Maximum Tolerated Dose (MTD) of TAK-659
  • Recommended Phase 2 Dose (RP2D) of TAK-659
Secondary Outcome:
  • Summary Statistics of TAK-659 Maximum Observed Concentration (Cmax) on Cycle 1 Days 1, 8 and 15 by Dose Escalation Cohort
  • Summary Statistics of TAK-659 Time of First Occurrence of Cmax (Tmax) on Cycle 1 Days 1, 8 and 15 by Dose Escalation Cohort
  • Summary Statistics of TAK-659 Area Under the Concentration-Time Curve During a Dosing Interval (AUCτ) on Cycle 1 Days 1, 8 and 15 by Dose Escalation Cohort
  • Overall Response Rate (ORR)
  • Duration of Response (DOR)
  • Time to Progression (TTP)
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 100 participants. Participants will be assigned to one of the 5 treatment groups:
  • TAK-659 + Bendamustine
  • TAK-659 + Bendamustine + Rituximab
  • TAK-659 + Gemcitabine
  • TAK-659 + Lenalidomide
  • TAK-659 + Ibrutinib This multi-centre trial will be conducted in North America and Europe. The overall time to participate in this study is approximately 27 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

These resources are provided in partnership with the Canadian Cancer Society