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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324129
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : January 8, 2015
Information provided by:
Mirati Therapeutics Inc.

Brief Summary:
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: MGCD0103 Phase 1

Detailed Description:
Phase I dose escalating study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: MGCD0103
MGCD0103 given orally three times per week.

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324129

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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.
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Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
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Responsible Party: Gregory Reid, Chief Medical Officer, MethylGene, Inc. Identifier: NCT00324129    
Other Study ID Numbers: 0103-003
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by Mirati Therapeutics Inc.:
Myelodysplastic Syndromes
Phase I
Additional relevant MeSH terms:
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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