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

January 6, 2015 updated by: Mirati Therapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase I dose escalating study.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer Davis-Jewish General Hospital
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MGCD0103
MGCD0103 given orally three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: 1 year (anticipated)
1 year (anticipated)
Safety and tolerability
Time Frame: 1 year (anticipated)
1 year (anticipated)

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose limiting toxicities
Time Frame: 1 year (anticipated)
1 year (anticipated)
Pharmacodynamics (histone acetylation, biomarkers)
Time Frame: 1 year (anticipated)
1 year (anticipated)
Clinical Response
Time Frame: 1 year (anticipated)
1 year (anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Investigators

  • Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0103-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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