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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00109538 |
The purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). Benefit will be measured by achievement of platelet transfusion independence for at least 8-consecutive weeks, and without simultaneous worsening of hemoglobin and/or need for red blood cell (RBC) transfusion. Additional endpoints will be hematologic response (which includes complete remission, partial remission, hematologic improvement), number of RBC transfusions, bleeding events, infections and safety.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelomonocytic |
Drug: Lonafarnib Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pivotal Randomized Study of Lonafarnib Versus Placebo in the Treatment of Subjects With Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) Who Are Platelet Transfusion Dependent With or Without Anemia |
Estimated Enrollment: | 200 |
Study Start Date: | May 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lonafarnib: Experimental
Lonafarnib 200 mg twice daily, oral, continuously
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Drug: Lonafarnib
200 mg twice daily (BID, ie, approximately 12 hours apart with food), oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
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Placebo: Placebo Comparator
Placebo, BID, oral
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Other: Placebo
BID, oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ECOG PS 0-2.
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Susan Arbuck, MD - Vice President, Global Clinical Research, Oncology ) |
Study ID Numbers: | P02978 |
Study First Received: | April 28, 2005 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00109538 |
Health Authority: | United States: Food and Drug Administration |
Lonafarnib |
Myelodysplastic syndromes Neural Tube Defects Precancerous Conditions Chronic myelomonocytic leukemia Nervous System Malformations Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelodysplastic Syndromes Anemia |
Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Myelodysplastic myeloproliferative disease Leukemia Preleukemia Neural tube defect, folate-sensitive Congenital Abnormalities Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease |
Neoplasms by Histologic Type Syndrome Nervous System Diseases |