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Sponsored by: |
MethylGene Inc. |
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Information provided by: | MethylGene Inc. |
ClinicalTrials.gov Identifier: | NCT00679133 |
In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days on / 7 days off schedule to patients with advanced malignancies to study its safety profile.
Condition | Intervention | Phase |
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Advanced Malignancies |
Drug: MGCD265 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: MGCD265
Oral daily administration; 7 days on / 7 days off
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MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.
In this study, oral MGCD265 is administered daily on a 7 days on / 7 days off schedule to patients with advanced malignancies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julie Dumouchel | 514-337-3333 ext 446 | dumouchelj@methylgene.com |
Contact: Tracy-Ann Patterson | 514-337-3333 ext 430 | pattersont@methylgene.com |
United States, Michigan | |
Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Study Director: | Robert Martell | MethylGene Inc. |
Responsible Party: | MethylGene Inc. ( Robert Martell / Chief Medical Officer ) |
Study ID Numbers: | 265-102 |
Study First Received: | May 14, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00679133 |
Health Authority: | United States: Food and Drug Administration |
c-Met VEGFR Ron Cancer |
Tumor Safety Phase 1 |
Neoplasms |