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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00321711 |
The purpose of this study is to evaluate the effect of AMG 531 on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk MDS receiving hypomethylating agents. It is hypothesized that AMG 531 administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.
Condition | Intervention | Phase |
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MDS Myelodysplastic Syndromes Thrombocytopenia |
Drug: Placebo Biological: AMG 531 |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents |
Estimated Enrollment: | 108 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dose Level 2 AMG 531 (Part B - decitabine): Active Comparator
Following DRT review of Part A, dose level in Part B will be confirmed. Dose level 2 AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles
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Biological: AMG 531
AMG 531 will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during the 4 cycle treatment period, depending on randomization.
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Dose Level 1 AMG 531 (Part B - decitabine): Active Comparator
Following DRT review of Part A, dose level in Part B will be confirmed. Dose level 1 AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles
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Biological: AMG 531
AMG 531 will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during the 4 cycle treatment period, depending on randomization.
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AMG 531 500 mcg (Part A - azacitidine): Active Comparator
500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles
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Biological: AMG 531
AMG 531 will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during the 4 cycle treatment period, depending on randomization.
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AMG 531 750 mcg (Part A - azacitidine): Active Comparator
750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles
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Biological: AMG 531
AMG 531 will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during the 4 cycle treatment period, depending on randomization.
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Placebo (Part A - azacitidine): Placebo Comparator
Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles
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Drug: Placebo
Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.
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Placebo (Part B - decitabine): Placebo Comparator
Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles
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Drug: Placebo
Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050232 |
Study First Received: | May 2, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00321711 |
Health Authority: | United States: Food and Drug Administration |
MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia |
Myelodysplastic syndromes Thrombocytopathy Preleukemia Thrombocytopenia Precancerous Conditions |
Hematologic Diseases Blood Platelet Disorders Myelodysplasia Myelodysplastic Syndromes Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Syndrome |