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

NCT ID: NCT00324129

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-12-31

Brief Summary

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

Detailed Description

Phase I dose escalating study.

Conditions

Leukemia; Myelodysplastic Syndromes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MGCD0103

Intervention Type: DRUG

MGCD0103 given orally three times per week.

Interventions

MGCD0103

MGCD0103 given orally three times per week.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

MethylGene, Inc.

Principal Investigators

Gregory Reid, MSc, MBA

Role: STUDY_DIRECTOR

MethylGene Inc.

Locations

Anderson Cancer Center

Houston, Texas, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Sir Mortimer Davis-Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

0103-003

Identifier Type: -

Identifier Source: org_study_id