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

Completed · Phase 1

Conditions studied: Leukemia, Myelodysplastic Syndromes

In brief

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

Key facts

Study ID

NCT00324129

Run by

Mirati Therapeutics Inc.

People needed

29

Starts

2005-02-01

Expected to finish

2008-12-01

Last updated by the study team

2015-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Anderson Cancer Center — Houston, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Sir Mortimer Davis-Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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