Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED)
This study has been terminated.
Merck Sharp & Dohme Corp.
First Posted: April 29, 2005
Last Update Posted: May 1, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelomonocytic||Drug: Lonafarnib Other: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Myelodysplastic/myeloproliferative DiseaseU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Proportion of subjects who achieved platelet transfusion independence for any 8-consecutive week period after randomization without worsening of RBC transfusion requirements or hemoglobin (untransfused) during the same 8-consecutive-week period. [ Time Frame: Any 8-consecutive week period after randomization ]
Secondary Outcome Measures:
- Hematologic response rate (CR, PR, HI), number of RBC transfusion events during a 4-week period, active bleeding events (number and severity), number of CTCAE Grade 3 and 4 infections and days of acute intervention, and safety. [ Time Frame: Any 8-consecutive week period after randomization ]
|Study Start Date:||May 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Lonafarnib 200 mg twice daily, oral, continuously
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
Other Name: SCH 66336
Placebo Comparator: Placebo
Placebo, BID, oral
BID, oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
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