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Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT00666497 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-05-08

No results posted yet for this study

Summary

The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.

Conditions

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)

Interventions

DRUG

Azacitidine

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

DRUG

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle

DRUG

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory Reid, MSc, MBA · MethylGene Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00666497 on ClinicalTrials.gov