NCT01640665

Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. The drug Capecitabine is approved to treat patients with advanced breast cancer as well as early stage colon cancer.

Detailed description

This is a pilot study of Sorafenib combined with Capecitabine in patients with histologically confirmed unresectable or metastatic breast and GI tumors. One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days

Conditions

• Metastatic Breast Cancer
• Gastrointestinal Tumors

Interventions

Type	Name	Description
DRUG	Sorafenib	One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses.
DRUG	Capecitabine	Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-07-16
• Last updated: 2016-09-16

Locations

1 site across 1 country: United States