Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer
Recruitment status was: Recruiting
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.
|Metastatic Breast Cancer||Drug: Sorafenib and Vinorelbine||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer|
- Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Sorafenib and Vinorelbine||
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.
Other Name: BAY 43-9006
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764972
|Contact: Lawrence Panasciemail@example.com|
|Contact: Cristiano Ferrariofirstname.lastname@example.org|
|Jewish General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T 1E2|
|Contact: Lawrence Panasci 514-340-8248 email@example.com|
|Contact: Cristiano Ferrario 514-340-8248 firstname.lastname@example.org|
|Principal Investigator: Lawrence Panasci|
|Principal Investigator:||Lawrence Panasci||McGill University|