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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Novartis |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00493571 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of gimatecan that can be given to treat myelodysplastic syndrome (MDS).
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes MDS |
Drug: Gimatecan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gimatecan |
Drug: Gimatecan
Starting dose: 0.6 mg capsules administered orally once daily.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jorge E. Cortes, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00493571 History of Changes |
| Other Study ID Numbers: | 2006-0943 |
| Study First Received: | June 27, 2007 |
| Last Updated: | September 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Myelodysplastic Syndromes MDS Gimatecan Leukemia |
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Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Neoplasms |