A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's Lymphoma

Official Title

A Phase Ib, Open-Label Study Evaluating The Safety And Pharmacokinetics Of GDC-0199 (ABT-199) In Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Chop) In Patients With B-Cell Non-Hodgkins Lymphoma (NHL) and DLBCL

Summary:

This is a multicentre, open-label, dose-finding study of GDC-0199 administered orally in combination with MabThera/Rituxan (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in patients with Non-Hodgkins Lymphoma (NHL). Patients will be randomized to one of two treatment arms of GDC-0199 in combination with R-CHOP and G-CHOP. The study will consist of two stages, a dose-finding stage and an expansion stage. The maximum tolerated dose (MTD) of GDC-0199 in combination with R-CHOP and G-CHOP will be determined during the dose-finding stage.

Trial Description

Primary Outcome:

  • Safety: Incidence of dose-limiting toxicities
  • Complete response (CR) defined by PET/CT scan and bone marrow examination
Secondary Outcome:
  • Relative dose intensity
  • Objective response (partial or complete response) rate
  • Response duration, defined as time from first documented response until relapse or death.
  • Safety: Incidence of adverse events
  • Progression-free survival
  • Overall survival
  • CR defined by CT scan and bone marrow examination
  • Pharmacokinetics: plasma concentration-time profile of GDC-0199

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society