A Phase 2 Study of ARQ 197 in Metastatic Triple-Negative Breast Cancer
If you take part in this research study, you will be given a study drug-dosing calendar for
each treatment cycle. Each treatment cycle lasts 3 weeks during which time you will be
taking the study drug twice daily for 21 days. During all cycles you will have a physical
exam and will be asked questions about your general healthy and specific questions about any
problems that you might be having and any medications you may be taking. Physical exams will
occur in clinic on screening, day 15, day 29, day 43 and every two weeks.
After the final dose of the study drug your research doctor will ask you to visit the office
for a follow-up exam approximately 30 to 37 days after discontinuing therapy. At this visit
you will have a physical exam, vital signs, blood tests and be asked about any symptoms you
may be experiencing since stopping ARQ 197. You will be followed approximately every 6
months after removal from the study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the Activity of ARQ-197
Evaluate the activity of ARQ-197, as defined as by 6-month Progression Free Survival (PFS) in Participants with triple-negative metastatic breast cancer.
Patients will be followed until disease progression
Sara Tolaney, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Dana-Farber Cancer Institute at Faulkner Hospital||Boston, Massachusetts 02215|