NCT00244972

Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer

Phase I Study of Tipifarnib (R115777) and Sorafenib (BAY 43-9006) in Patients With Biopsiable Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (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 when given together with sorafenib tosylate in treating patients with biopsiable cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Tipifarnib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity and to determine maximum tolerated dose (MTD) of tipifarnib in combination with sorafenib (sorafenib tosylate). SECONDARY OBJECTIVES: I. Preliminary assessment of tipifarnib and sorafenib efficacy (objective response). II. To determine signaling pathway profiles of patients treated with tipifarnib and sorafenib who are amenable to biopsy by reverse phase protein microarray (RPPA) analysis. OUTLINE: This is a dose-escalation study of tipifarnib. Patients receive sorafenib tosylate orally (PO) once daily (QD) or twice daily (BID) on days 1-28 and tipifarnib PO QD or BID on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients may be allowed to continue the treatment after the 12 courses if there is continued clinical response or disease stabilization, and patients do not have significant toxicities. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Advanced Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Sorafenib Tosylate	Given PO
DRUG	Tipifarnib	Given PO

Timeline

• Start date: 2005-10-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2005-10-27
• Last updated: 2017-04-27

Locations

1 site across 1 country: United States