The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose. (This portion of the study is complete). The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. \- 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. \- 40 patients with SCLC
Site Reference ID/Investigator# 13605
Peoria, Arizona, United States
Site Reference ID/Investigator# 5261
Phoenix, Arizona, United States
Safety assessment
Time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Dose limiting toxicity determination
Time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Maximum tolerated dose determination
Time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Pharmacokinetic profile evaluation
Time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Extended safety assessment at the recommended Phase 2 dose
Time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Preliminary efficacy assessment
Time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
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Site Reference ID/Investigator# 11942
Los Angeles, California, United States
Site Reference ID/Investigator# 4718
Sacramento, California, United States
Site Reference ID/Investigator# 3755
Aurora, Colorado, United States
Site Reference ID/Investigator# 8324
Atlanta, Georgia, United States
Site Reference ID/Investigator# 2623
Chicago, Illinois, United States
Site Reference ID/Investigator# 2625
Baltimore, Maryland, United States
Site Reference ID/Investigator# 12343
Bethesda, Maryland, United States
Site Reference ID/Investigator# 11941
Boston, Massachusetts, United States
...and 8 more locations