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A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes

This study has been completed.
Information provided by:
Mirati Therapeutics Inc. Identifier:
First received: May 8, 2006
Last updated: January 6, 2015
Last verified: January 2015
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.

Condition Intervention Phase
Leukemia Myelodysplastic Syndromes Drug: MGCD0103 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes

Resource links provided by NLM:

Further study details as provided by Mirati Therapeutics Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year (anticipated) ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ]

Secondary Outcome Measures:
  • Clinical Response [ Time Frame: 1 year (anticipated) ]
  • Dose limiting toxicities [ Time Frame: 1 year (anticipated) ]
  • Pharmacodynamics (histone acetylation, biomarkers) [ Time Frame: 1 year (anticipated) ]

Enrollment: 29
Study Start Date: February 2005
Study Completion Date: December 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MGCD0103
MGCD0103 given orally three times per week.

Detailed Description:
Phase I dose escalating study.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a diagnosis of one of the following:

    • relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy
    • relapsed or refractory Myelodysplastic Syndromes
    • previously untreated AML or Myelodysplastic Syndromes in patients > 60 years of age who refused or are not candidates for induction chemotherapy
  • Patients with relapsed or refractory CML that has failed to respond to Imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists
  • ECOG performance status of 0, 1, or 2
  • Age ≥ 18 years
  • Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry

Exclusion Criteria:

  • Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia
  • Pregnant or lactating women
  • Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the study and for 90 days following the last dose of study medication
  • Patients with known meningeal metastasis(es)
  • Patients with active or uncontrolled infections, or with a fever >38.5 C
  • Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study
  • Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00324129

United States, Texas
Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Mirati Therapeutics Inc.
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
  More Information

Responsible Party: Gregory Reid, Chief Medical Officer, MethylGene, Inc. Identifier: NCT00324129     History of Changes
Other Study ID Numbers: 0103-003
Study First Received: May 8, 2006
Last Updated: January 6, 2015

Keywords provided by Mirati Therapeutics Inc.:
Myelodysplastic Syndromes
Phase I

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on July 27, 2017