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Sponsors and Collaborators: |
Celgene Corporation MethylGene Inc. |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00372437 |
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours.
Condition | Intervention | Phase |
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Tumors |
Drug: MGCD0103 Drug: Gemcitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine |
Enrollment: | 47 |
Study Start Date: | September 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: MGCD0103
MGCD0103 as an oral dose three times per week.
Drug: Gemcitabine
Gemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with known CNS metastases may be enrolled on Phase I or II only if they meet the following criteria:
Laboratory requirements (must be done within 14 days prior to study initiation):
Exclusion Criteria:
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kansas | |
Veterans Affairs Medical Center | |
Kansas City, Kansas, United States, 64128 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Gabrail Cancer Center | |
Canton, Ohio, United States, 44718 | |
United States, Pennsylvania | |
Pennsylvania Presbyterian Medical Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-6307 | |
Canada, Quebec | |
McGill University/Dept Oncology | |
Montreal, Quebec, Canada, H2W 1S6 | |
CHUS Hopital Fleurimont | |
Sherbrooke, Quebec, Canada, J1H 5N4 |
Study Director: | Pascal Brabant | MethylGene Inc. |
Responsible Party: | MethylGene, Inc. ( Pascal Brabant, Director Clinical Operations ) |
Study ID Numbers: | MGCD0103-006 |
Study First Received: | September 5, 2006 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00372437 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Refractory solid tumors Phase I/II Refractory and solid tumors |
Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |