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
Interventional Study Design - Primary Purpose: Determination of safety and tolerability
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of dose limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase two dose (RPTD), and lead-in period regimen
Protocol-defined events, which can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, underlying illness, concurrent illness, or concomitant medication, will be considered a DLT. Dose limiting toxicities of tumor lysis syndrome observed during the lead-in period will be attributed to the lead-in period.
Lead-in period (2-5 weeks) plus 3 weeks of study drug administration at the designated cohort dose (continuous dosing)
Yes
Sari Enschede, MD
Study Director
AbbVie
Australia: Department of Health and Ageing Therapeutic Goods Administration
M12-175
NCT01328626
June 2011
July 2014
Name | Location |
---|---|
Site Reference ID/Investigator# 52902 | Tucson, Arizona 85724-5024 |
Site Reference ID/Investigator# 48325 | La Jolla, California 92093 |
Site Reference ID/Investigator# 48324 | Boston, Massachusetts 02115 |
Site Reference ID/Investigator# 56810 | New York, New York 10065 |
Site Reference ID/Investigator# 48326 | Houston, Texas 77030-4009 |
Site Reference ID/Investigator# 52882 | Seattle, Washington 98109 |
Site Reference ID/Investigator# 56811 | Madison, Wisconsin 53705-2275 |