Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00764972|
Recruitment Status : Unknown
Verified October 2008 by McGill University.
Recruitment status was: Recruiting
First Posted : October 2, 2008
Last Update Posted : October 21, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Sorafenib and Vinorelbine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2011|
|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
- Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764972
|Contact: Lawrence Panascifirstname.lastname@example.org|
|Contact: Cristiano Ferrarioemail@example.com|
|Principal Investigator:||Lawrence Panasci||McGill University|