Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer
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.
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Investigator Initiated, Phase II Study of Linifanib in Patients With Advanced, Refractory Colorectal Cancer Expressing Mutated kRas|
- Overall response rate with a target of at least 15% [ Time Frame: Baseline, day 1 of each odd numbered course, and at end of study ] [ Designated as safety issue: No ]Defined as the best response recorded from the start of the treatment until disease progression/recurrence, the exact two-sided 95% confidence intervals will be reported.
- Progression-free survival [ Time Frame: Every 3 months for 2 years and then every 6 months for 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 3 months for 2 years and then every 6 months for 3 years ] [ Designated as safety issue: No ]
- Toxicity profile of ABT 869 (linifanib) in this patient population [ Time Frame: Days 1 and 14 of course 1, day 1 of each subsequent course, and at 30 day follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor)
Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
I. To achieve an overall response rate of 15% or more.
I. Determine progression free survival. II. Determine overall survival. III. Evaluate toxicity profile of ABT 869 (linifanib) in this patient population.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365910
|United States, Tennessee|
|Vanderbilt Cool Springs|
|Franklin, Tennessee, United States, 37067|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Jordan Berlin, MD||Vanderbilt-Ingram Cancer Center|