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


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

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Canadian Cancer Society

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