Advanced Malignant Neoplasm Clinical Trial
Official title:
Phase I Study of Tipifarnib (R115777) and Sorafenib (BAY 43-9006) in Patients With Biopsiable Advanced Cancers
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.
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.
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