Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the hematological response rate, as well as other parameters of efficacy and safety induced by tipifarnib in patients with high-risk myelodysplastic syndrome (MDS). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Tipifarnib

Criteria

Inclusion Criteria:

• Pathological evidence of MDS

• Not more than 1 prior cytotoxic treatment for MDS

• Able to take oral study drug

• Able to understand and provide signed informed consent

Exclusion Criteria:

• Refractory anemia (RA) or RA with excess of blasts (RAEB) or patients with RAEB with < or = 10% marrow blasts

• Treatment-related MDS, if treated with chemotherapy less than 3 years ago

• Not adequately recovered from any treatment-related non-hematological toxicity

• Refractory to platelet transfusion

• Candidates for hematopoietic stem cell transplantation

• Previous therapy with a farnesyl transferase inhibitor

• Prior extensive radiation therapy