Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Rectal Neoplasms

Colonic Neoplasms

Disease Attributes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Tyrosine

Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

linifanib

Jordan Berlin, MD

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.

Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer

An Investigator Initiated, Phase II Study of Linifanib in Patients With Advanced, Refractory Colorectal Cancer Expressing Mutated kRas

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.

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.

Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring.

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

Vanderbilt-Ingram Cancer Center

Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist

Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

linifanib: Given PO

Treatment (Enzyme Inhibitor)

Age 20-29

Age 40-49

Age 50-59

Age 60-69

Age 70-79

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Dr. Jordan Berlin

All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.

Overall Response Rate (Complete Response + Partial Response) With a Target of at Least 15%

All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.

Progression-free Survival

Overall Survival

worst grade toxicity 1

worst grade toxicity 2

worst grade toxicity 3

worst grade toxicity 4

worst grade toxicity 5

Total number of patients reported with any toxicity

Number of Patients With Each Worst-Grade Toxicity

ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.

Overall Study

Spots Global Cancer Trial Database for Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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