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

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

Detailed Description
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Phase I dose escalating study.

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

Conditions
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Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
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* Drug: MGCD0103


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MGCD0103<br>* MGCD0103 given orally three times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 1 year (anticipated) | 
| Pharmacokinetics |  | 1 year (anticipated) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Myelodysplastic Syndromes, Phase I