An Adaptive Phase 2 Study of Tipifarnib in Subjects withTransfusion-dependent, Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

Protocol: 
AAAQ7125
Phase: 
II

An Adaptive Phase 2 Study of Tipifarnib in Subjects withTransfusion-dependent, Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

The main purpose of this study is to see how effective an investigational new drug (tipifarnib, the study drug) is to treat your disease. Investigational means that tipifarnib has not yet been approved by regulatory authorities such as the United States Food and Drug Administration (FDA) for use outside of clinical trials.

Are you Eligible? (Inclusion Criteria)

1) Must have transfusion-dependent anemia that meets the following criteria:
a. Average transfusion requirement of >= 2 units per 28 days of packed RBCs confirmed for a
minimum of 112 days immediately preceding Cycle 1 Day 1.
b. No consecutive 56 days that was RBC transfusion-free during the 112 days immediately
preceding Cycle 1 Day 1.
c. Hemoglobin levels at the time of or within 7 days prior to transfusions must have been <= 9.0 g/dL for the transfusions to qualify as required for the purpose of providing evidence of
transfusion-dependent anemia.
2) Must be unresponsive or refractory to erythropoiesis-stimulating agents (ESA), based on one of the following:
a. Transfusion-dependence in subjects previously treated with an ESA (requires a minimum ESA trial of > 40,000 U/week recombinant human erythropoietin (rHuEPO) x 8 weeks or equivalent dose of darbepoetin or other erythropoietin agent), or
b. Serum erythropoietin

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States