A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

May 23, 2011

Primary Completion Date

May 8, 2020

Study Completion Date

May 8, 2020

Conditions
Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
Interventions
DRUG

ABT-199

Arm A (Cohorts 1-8) and Arm B (Cohort 1-6): Subjects in dose escalation phase will receive 1 dose of ABT-199, followed by 6 days off drug, followed by continuous once daily dosing with ABT-199. Arm B (Cohorts 7+): Subjects in dose escalation phase will receive continuous once daily dosing with ABT-199. Arm A and Arm B: Subjects in expanded safety cohort will receive continuous once daily dosing with ABT-199.

Trial Locations (10)

3000

Peter MacCallum Cancer Ctr /ID# 48323, Melbourne

3050

Royal Melbourne Hospital /ID# 48322, Parkville

77030

University of Texas MD Anderson Cancer Center /ID# 48326, Houston

92093

Ucsd /Id# 48325, La Jolla

98104

Swedish Medical Center /ID# 135853, Seattle

98109

Fred Hutchinson Cancer Research /ID# 52882, Seattle

85719-1478

University of Arizona Cancer Center - North Campus /ID# 52902, Tucson

02215

Dana-Farber Cancer Institute /ID# 48324, Boston

10065-6007

Memorial Sloan Kettering Cancer Center /ID# 56810, New York

53792-0001

Univ of Wisconsin Hosp/Clinics /ID# 56811, Madison

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY