A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes
Study Details
Study Description
Brief Summary
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
Phase I dose escalating study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 1
|
Drug: MGCD0103
MGCD0103 given orally three times per week.
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Outcome Measures
Primary Outcome Measures
- Safety and tolerability [1 year (anticipated)]
- Pharmacokinetics [1 year (anticipated)]
Secondary Outcome Measures
- Clinical Response [1 year (anticipated)]
- Dose limiting toxicities [1 year (anticipated)]
- Pharmacodynamics (histone acetylation, biomarkers) [1 year (anticipated)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must have a diagnosis of one of the following:
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relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy
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relapsed or refractory Myelodysplastic Syndromes
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previously untreated AML or Myelodysplastic Syndromes in patients > 60 years of age who refused or are not candidates for induction chemotherapy
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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
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ECOG performance status of 0, 1, or 2
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Age ≥ 18 years
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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:
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Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia
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Pregnant or lactating women
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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
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Patients with known meningeal metastasis(es)
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Patients with active or uncontrolled infections, or with a fever >38.5 C
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Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study
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Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Anderson Cancer Center | Houston | Texas | United States | 77030 |
2 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
3 | Sir Mortimer Davis-Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
Sponsors and Collaborators
- Mirati Therapeutics Inc.
Investigators
- Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0103-003