Recurrent Rectal Cancer Clinical Trial
Official title:
An Investigator Initiated, Phase II Study of Linifanib in Patients With Advanced, Refractory Colorectal Cancer Expressing Mutated kRas
This phase II trial studies how well Linifanib works in treating patients with advanced, refractory colorectal cancer expressing k-Ras mutations. Linifanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To achieve an overall response rate of 15% or more.
SECONDARY OBJECTIVES:
I. Determine progression free survival. II. Determine overall survival. III. Evaluate
toxicity profile of ABT 869 (linifanib) in this patient population.
OUTLINE:
Patients receive Linifanib orally (PO) once daily (QD). Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for
2 years, and then every 6 months for 3 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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