A Phase 3 interventional study of Lonafarnib and Placebo in Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic and Myelodysplasia, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-01.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 47 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.
Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
ECOG PS 0-2.
Exclusion Criteria:
Lonafarnib 200 mg twice daily, oral, continuously
Drug: Lonafarnib
Placebo, BID, oral
Other: Placebo
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
Also known as: SCH 66336
BID, oral, continuously, or until unacceptable toxicity or transformation to AML, or disease progression, or other discontinuation criteria
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
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
No study locations are listed for this record.
This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC