A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer
Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug
nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein
layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression
of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered
investigational which means it has not been approved by the US Food and Drug Administration,
FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly
3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of
nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth.
Participants will continue to receive study treatment as long as their tumor responds. If
the tumor does not respond or the participant experience severe side effects from study
treatment, she will be removed from the study and offered other therapies, if that is
appropriate.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC).
labs drawn weekly
Yes
Mary Cianfrocca, DO
Principal Investigator
Northwestern University
United States: Institutional Review Board
NU 08B7
NCT00983424
February 2010
February 2016
Name | Location |
---|---|
Northwestern University, Northwestern Medical Faculty Foundation | Chicago, Illinois 60611-3013 |