NCT00764972

Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer

A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: McGill University · Academic / Other
• Sex: Female
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer. The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients. Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib and Vinorelbine	vinorelbine, administered as a brief infusion twice every three weeks (on day 1 and 8 of 21-day cycles); sorafenib, that you will take orally every day, at the dosage that your study doctor will prescribe.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2008-10-02
• Last updated: 2008-10-21

Locations

1 site across 1 country: Canada