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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110473 on ClinicalTrials.gov