The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose in subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263 using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy in subject with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects who remain active 1 year after the last subject enrolls or who have been on study approximately 1 year to continue receiving ABT-263 with less frequent study evaluations. Subjects in the Extension Study will continue receiving study drug for up to 7 years after the last subject transitions to the Extension Study, or until disease progression or toxicity that necessitates discontinuation (whichever comes first).
Enrollment breakdown: Entered Study: Phase 1a: 39; Phase 1b: 19; Phase 2a: 33; Total: 91 Entered Treatment: Phase 1a: 38; Phase 1b: 17; Phase 2a: 26; Total: 81
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Oral solution Phase 1 dosing was under two different schedules: 14 days on drug, 7 days off or 21 days continuous dosing. Oral solution and tablets Phase 2a dosing under 21 day continuous dosing. \- 150 mg lead-in dose for 7-14 days followed by a 325 mg continuous once daily dose.
Site Reference ID/Investigator# 4997
Los Angeles, California, United States
Site Reference ID/Investigator# 9104
Los Angeles, California, United States
Site Reference ID/Investigator# 2613
Bethesda, Maryland, United States
Site Reference ID/Investigator# 40243
Boston, Massachusetts, United States
Site Reference ID/Investigator# 4745
Boston, Massachusetts, United States
Site Reference ID/Investigator# 2628
Buffalo, New York, United States
Site Reference ID/Investigator# 23543
New York, New York, United States
Site Reference ID/Investigator# 2627
New York, New York, United States
Site Reference ID/Investigator# 2614
New York, New York, United States
Site Reference ID/Investigator# 5383
New York, New York, United States
...and 2 more locations
Phase 1a: Determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) and schedule - intermittent dosing.
1a: Determination of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 14/21 day dosing schedule
Time frame: Repeating sequence of 14 days on therapy and 7 days off.
Phase 1b: Determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) and schedule - continuous dosing.
Phase 1b: Determination of ABT-263 dose limiting toxicity (DLT) and maximum tolerated dose (MTD) under a 21 day continuous dosing schedule.
Time frame: 21 day continuous dosing.
Phase 2a: Continued assessment of safety profile at the recommended Phase 2 dose (RPTD) and schedule - continuous dosing.
Phase 2a: Continued assessment of the safety profile of ABT-263 at the Recommended Phase 2 Dose (RPTD) and schedule under a 21 day continuous dosing.
Time frame: 21 day continuous dosing.
Phase 2a: Assessment of preliminary efficacy signals including biomarker assessment - continuous dosing.
Phase 2a: Assessment of the preliminary efficacy signals of ABT-263, including biomarker assessment, at the Recommended Phase 2 Dose (RPTD) and schedule under a 21 day continuous dosing.
Time frame: 21 day continuous dosing.
Extension Study: Continued assessment of the safety profile of ABT-263
Continued assessment of the safety profile of ABT-263.
Time frame: 21 day continuous dosing
Extension Study: Continued assessment of the preliminary efficacy signals of ABT-263.
Continued assessment of the preliminary efficacy signals of ABT-263.
Time frame: day continuous dosing
Phase 1a or Phase 1b safety assessment
Assessment of the safety of ABT-263
Time frame: Repeating sequence of 14 days on therapy and 7 days off OR 21 day continuous dosing.
Phase 1a, Phase 1b, or Phase 2a pharmacokinetic profile evaluation
Evaluation of pharmacokinetic profile of ABT-263.
Time frame: Repeating sequence of 14 days on therapy and 7 days off OR 21 day continuous dosing.
Phase 1a effect of food on bioavailability
Evaluation of the effect of food on bioavailability
Time frame: Repeating sequence of 14 days on therapy and 7 days off.
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