NCT00005845

Tipifarnib in Treating Patients With Myelodysplastic Syndromes

Phase I Study of the Farnesyl Transferase Inhibitor R115777 (NSC #702818) in Patients With Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of tipifarnib in treating patients with myelodysplastic syndromes. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the toxicity profile and antitumor activity of the farnesyltransferase (FTase) inhibitor R115777 (tipifarnib) in patients with myelodysplastic syndrome (MDS) treated on a one week on/one week off schedule. II. To determine the effect on R115777 on a one week on/one week off schedule on FTase activity, prenylation of RAS and other substrates and on downstream effects. OUTLINE: This is a dose-escalation study. Patients receive tipifarnib orally (PO) twice daily (BID) on weeks 1, 3, 5, and 7. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Conditions

• Chronic Myelomonocytic Leukemia
• de Novo Myelodysplastic Syndromes
• Previously Treated Myelodysplastic Syndromes
• Refractory Anemia
• Refractory Anemia With Excess Blasts
• Refractory Anemia With Excess Blasts in Transformation
• Refractory Anemia With Ringed Sideroblasts
• Refractory Cytopenia With Multilineage Dysplasia

Interventions

Type	Name	Description
DRUG	tipifarnib	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2002-06-01
• Primary completion: 2009-09-01
• First posted: 2003-08-29
• Last updated: 2013-12-16

Locations

1 site across 1 country: United States