ABT-348 as Monotherapy and in Combination With Azacitidine to Treat Advanced Hematologic Malignancies
NCT01110473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2017-11-20
Summary
The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with azacitidine.
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myelogenous Leukemia
- B-cell Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia
- Myelodysplasia
Interventions
- DRUG
-
ABT-348
An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
- DRUG
-
ABT-348
An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle
- DRUG
-
ABT-348 and azacitidine
An oral dose of ABT-348 on Day 1, Day 8, and Day 15 of each 28 day cycle. An IV or injection of azacitidine on Days 1-7 of each 28 day cycle.
- DRUG
-
ABT-348
An intravenous dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
Sponsors & Collaborators
-
AbbVie (prior sponsor, Abbott)
lead INDUSTRY
Principal Investigators
-
Gary Gordon, MD · AbbVie
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- United States
Study Locations
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