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Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)

NCT00989261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2019-12-11

Study results available
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Summary

AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).

Conditions

Interventions

DRUG

Compound AC220

Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.

Sponsors & Collaborators

Principal Investigators

  • Interim Chief Medical Officer · Ambit Biosciences Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-09-28
Completion
2014-12-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00989261 on ClinicalTrials.gov