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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00117507 |
Thirty patients will be enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study will have low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients will initiate treatment with 20mg/kg/day deferasirox.
Deferasirox will be administered orally once per day for 12 months.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes Iron Overload |
Drug: deferasirox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-Risk and INT-1 Myelodysplastic Patients |
Enrollment: | 24 |
Study Start Date: | April 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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20mg/kg/day deferasirox: Experimental
Deferasirox will be administered orally once per day for 12 months. Surrogate marker findings, including serum ferritin, and LIC in the context of the study results will be monitored on a regular basis for any indications of clinically important over- or under-chelation.
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Drug: deferasirox
deferasirox 20 mg/kg/day taken over one year.Deferasirox should be taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets should be dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
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Patients will be screened for eligibility to determine if they meet all inclusion/exclusion criteria. The screening period will be up to 4 weeks. Patient's baseline LIC will be determined non-invasively by means of MRI R2 analysis. In addition, blood and urine samples will be taken for the determination of baseline safety data.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Serum ferritin:
Exclusion Criteria:
Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5821 | |
United States, Michigan | |
Karmanos Cancer Center | |
Detroit, Michigan, United States, 48201 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CICL670AUS02 |
Study First Received: | June 30, 2005 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00117507 |
Health Authority: | United States: Food and Drug Administration |
MDS Myelodysplastic Syndrome ICL-670 ICL-670 and Myelodysplastic Syndrome |
Myelodysplastic syndromes Metabolic Diseases Precancerous Conditions Hematologic Diseases Deferasirox Myelodysplastic Syndromes Myelodysplasia |
Iron Metabolism Disorders Preleukemia Iron Overload Bone Marrow Diseases Metabolic disorder Iron |
Neoplasms Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Syndrome Iron Chelating Agents Chelating Agents Pharmacologic Actions |