NCT01110473

ABT-348 as Monotherapy and in Combination With Azacitidine to Treat Advanced Hematologic Malignancies

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-348 as Monotherapy and in Combination With Azacitidine in Subjects With Advanced Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of this study are to determine safety and pharmacokinetics of ABT-348 as monotherapy and when given in combination with azacitidine. The secondary objectives are to determine the maximum tolerated dose and recommended Phase 2 dose of ABT-348 when administered as monotherapy and when given in combination with azacitidine in subjects with advanced hematologic malignancies.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• B-cell Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Myelodysplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-04-26
• Last updated: 2017-11-20

Locations

3 sites across 1 country: United States