Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED)
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Myelodysplasia
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Lonafarnib
Eligibility Criteria
Inclusion Criteria: Confirmed MDS (RA, RARS, RAEB, RAEB-T) or CMML according to FAB classification. Platelet transfusion dependence (requiring 1 to 8 platelet transfusion events every 4 week period (Day 84 to Day 57, Day 56 to Day 29, and Day 28 to Day 1) over an 8-week retrospective and 4-week prospective screening period). The individual number of platelet transfusion events during the three 4-weekly periods (Day 84 to Day -57; Day -56 to Day 29; Day -28 to Day -1) must not differ by greater more than 2 from the average number of platelet transfusion events during the 12 week screening period. If the subject is RBC transfusion dependent, the number of RBC transfusion events during the three 4-weekly periods (Days -84 to -57; Day -56 to Day 29 and Day -28 to Day -1) must not differ by more than 2 from the average number of RBC transfusion events during this 12 week screening period. ECOG PS 0-2. Exclusion Criteria: Subjects with chemotherapy/radiotherapy-associated secondary MDS. <12 Weeks (prior to Day-1 Randomization) from any investigational drug use, any chemotherapy, radiotherapy, immunotherapy and any other treatment or MDS/CMML other than best supportive care. Hx of bone-marrow or peripheral stem-cell transplantation or treatment with donor lymphocyte infusion. Hx of AML. Known hx of immune thrombocytopenic purpura. Marked baseline prolongation of QTc interval, CTCAE Grade >=1. Use of ketokonazole within 72 hours prior to study drug administration.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lonafarnib
Placebo
Lonafarnib 200 mg twice daily, oral, continuously
Placebo, BID, oral