Myelodysplastic Syndrome Clinical Trial

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

Summary

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

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Full Description

Phase I dose escalating study.

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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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

29

Study ID:

NCT00324129

Recruitment Status:

Completed

Sponsor:

Mirati Therapeutics Inc.

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There are 3 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

29

Study ID:

NCT00324129

Recruitment Status:

Completed

Sponsor:


Mirati Therapeutics Inc.

How clear is this clinincal trial information?

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