Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer
Tumor tissue will be tested for the presence of the pStat3 marker. Patients with a positive
test will be potentially eligible for study treatment (ruxolitinib). Patients with a
negative test will not be eligible to join the treatment portion of the study.
Participants with breast cancer that is accessible to a biopsy will undergo a research
biopsy procedure prior to beginning ruxolitinib. This biopsy is required as part of study
participation so research doctors can learn more about pSTAT3 as a marker for breast cancer.
Participatns will be given a drug-dosing calendar for each treatment cycle. Each treatment
cycle lasts 4 weeks, during which time the study drug will be taken by mouth twice a day
every day beginning on cycle 1 day 1.
During all cycles participants will undergo a physical exam, be asked questions about their
general health, be askd specific questions about any problems that they might be having and
any medications they may be taking.
Participants will also undergo blood tests, have tumor markers drawn, be asked to complete
health-realted questionnaires, and undergo body scans to assess the effects of ruxolitinib
on your tumor(s).
Partipant's medical condition will be followed for up to 2 years following study completion.
This will happen through medical record reviews as well as phone calls to the participant or
partipants' doctor.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response by RECIST 1.1
Objective response by RECIST 1.1
2 years
No
United States: Food and Drug Administration
12-024
NCT01562873
June 2012
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |