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

This study has been completed.
Sponsor:
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00324129
First received: May 8, 2006
Last updated: April 28, 2011
Last verified: May 2009
  Purpose

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
Endpoint Classification: Safety Study
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 MethylGene Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Response [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Dose limiting toxicities [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics (histone acetylation, biomarkers) [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324129

Locations
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
MethylGene Inc.
Investigators
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
  More Information

No publications provided

Responsible Party: Gregory Reid, Chief Medical Officer, MethylGene, Inc.
ClinicalTrials.gov Identifier: NCT00324129     History of Changes
Other Study ID Numbers: 0103-003
Study First Received: May 8, 2006
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
Leukemia
Myelodysplastic Syndromes
Phase I

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
N-(2-aminophenyl)-4-((4-pyridin-3-ylpyrimidin-2-ylamino)methyl)benzamide
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014