Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer
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 (Complete Response + Partial Response) With a Target of at Least 15% [ Time Frame: Baseline and every 8 weeks, up to 2 years ] [ Designated as safety issue: No ]Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Defined as the CR + PR 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, up to 2 years ] [ Designated as safety issue: No ]Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.
- Overall Survival [ Time Frame: Every 3 months, up to 2 years ] [ Designated as safety issue: No ]Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring.
- Number of Patients With Each Worst‐Grade Toxicity [ Time Frame: date on‐study up to 2 years following final dose of study ] [ Designated as safety issue: Yes ]
Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1= mild; grade 2 = moderate; grade 3 = severe; grade 4 = life‐threatening; grade 5 = death
Assessed: days 1 &15 of cycle 1; day 1 of each subsequent 28-day cycle; at 30-day follow-up for two years
|Study Start Date:||June 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2012 (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|