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

Sponsor
McGill University
Study ID
NCT00764972
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sorafenib and Vinorelbine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2007
Status verified
Oct 2008
Primary completion
Dec 31, 2010
Completion
Dec 31, 2011

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sorafenib and Vinorelbine

Primary Outcome Measure

Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.

Central Contacts

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