Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED)

Last updated: April 9, 2015
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Terminated

Phase

3

Condition

Leukemia

Myelodysplastic Syndromes (Mds)

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT00109538
P02978
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 4week period (Day 84 to Day 57, Day 56 to Day 29, and Day 28 to Day 1) over an 8-weekretrospective 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 greatermore than 2 from the average number of platelet transfusion events during the 12 weekscreening period.

  • If the subject is RBC transfusion dependent, the number of RBC transfusion eventsduring the three 4-weekly periods (Days -84 to -57; Day -56 to Day 29 and Day -28 toDay -1) must not differ by more than 2 from the average number of RBC transfusionevents during this 12 week screening period. ECOG PS 0-2.

Exclusion

Exclusion Criteria:

  • Subjects with chemotherapy/radiotherapy-associated secondary MDS.

  • <12 Weeks (prior to Day-1 Randomization) from any investigational drug use, anychemotherapy, radiotherapy, immunotherapy and any other treatment or MDS/CMML otherthan best supportive care.

  • Hx of bone-marrow or peripheral stem-cell transplantation or treatment with donorlymphocyte 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.

Study Design

Total Participants: 47
Study Start date:
May 01, 2005
Estimated Completion Date:
August 31, 2008