NCT02402036

A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.

Detailed description

Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for protein, miRNA, and mutated DNA analysis.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib orally for 21 days every 28 day cycle

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-03-30
• Last updated: 2019-01-29
• Results posted: 2019-01-29

Locations

1 site across 1 country: United States