Trials / Terminated
TerminatedNCT01365910
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Vanderbilt-Ingram Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Stage IVA Colon Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Rectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | linifanib | Given PO |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-05-01
- Completion
- 2013-06-01
- First posted
- 2011-06-03
- Last updated
- 2014-08-26
- Results posted
- 2014-08-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01365910. Inclusion in this directory is not an endorsement.