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Sponsors and Collaborators: |
Celgene Corporation MethylGene Inc. |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00324129 |
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: MGCD0103 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes |
Enrollment: | 29 |
Study Start Date: | February 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: MGCD0103
MGCD0103 given orally three times per week.
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Phase I dose escalating study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have a diagnosis of one of the following:
Exclusion Criteria:
United States, Texas | |
Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Sir Mortimer Davis-Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 |
Study Director: | Pascal Brabant | MethylGene Inc. |
Responsible Party: | MethylGene, Inc. ( Pascal Brabant, Director Clinical Operations ) |
Study ID Numbers: | MGCD0103-003 |
Study First Received: | May 8, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00324129 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Leukemia Myelodysplastic Syndromes Phase I |
Myelodysplastic syndromes Leukemia Preleukemia Precancerous Conditions |
Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |