A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL.
Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days
Yes
Sari Enschede, MD
Study Director
AbbVie
United States: Food and Drug Administration
M10-458
NCT00868413
November 2009
May 2013
Name | Location |
---|---|
Site Reference ID/Investigator# 17841 | La Jolla, California 92093-0820 |
Site Reference ID/Investigator# 25899 | Stanford, California 94305-5821 |
Site Reference ID/Investigator# 21622 | Baltimore, Maryland 21231-1000 |
Site Reference ID/Investigator# 21621 | Columbus, Ohio 43210 |
Site Reference ID/Investigator# 39613 | Philadelphia, Pennsylvania 19111 |
Site Reference ID/Investigator# 17943 | Houston, Texas 77030-4009 |