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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00750334 |
This study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes |
Drug: clofarabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open-Label, Dose-Finding and Food Effect Study of Oral Clofarabine in Previously Treated Adult Patients With Myelodysplastic Syndromes (MDS) |
Estimated Enrollment: | 48 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part A: Experimental
clofarabine Dose Escalation
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Drug: clofarabine
Drug given Daily x 14 days and 7 days of rest for 21 day cycle
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Part B: Experimental
Part B is an open-label, replicated cross-over study in which 12 additional patients will be enrolled and treated at the MTD determined in part A to evaluate the effect of food on the PK disposition of oral clofarabine.
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Drug: clofarabine
Drug given Daily X 14 days and 7 days of rest for 21 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:
Exclusion Criteria:
Contact: Genzyme MedInfo | 800-745-4447 | medinfo@genzyme.com |
United States, Florida | |
Malignant Hematology Administration, H. Lee Moffitt Cancer Center | Recruiting |
Tampa, Florida, United States | |
United States, Minnesota | |
Division of Hematology Mayo Clinic | Recruiting |
Rochester, Minnesota, United States | |
United States, Texas | |
Cancer Care Centers of South Texas | Recruiting |
San Antonio, Texas, United States |
Study Director: | Reginald Ewesuedo, MD | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CLOMDS01206 |
Study First Received: | September 9, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00750334 |
Health Authority: | United States: Food and Drug Administration |
Oral Clofarabine, relapsed/refractory MDS, Myelodysplastic |
Clofarabine Myelodysplastic syndromes Signs and Symptoms Preleukemia Precancerous Conditions |
Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Antineoplastic Agents |
Therapeutic Uses Syndrome Pharmacologic Actions |