A Phase 2 Study of ARQ 197 in Metastatic Triple-Negative Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
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.
Inclusion Criteria:
- Histologically or cytologically confirmed, triple-negative (ER-, PR-, HER2-) invasive
breast cancer with recurrent or metastatic disease
- Measurable disease
- Must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer m
- Must have been off treatment with chemotherapy, biologic therapy, investigational
therapy and radiation therapy for at least 14 days before enrollment in the study
- ECOG performance status of less than or equal to 2
- Either the primary tumor or the metastasis must be triple-negative
- Confirmed availability of FFPE tumor tissue
Exclusion Criteria:
- Pregnant or breastfeeding
- Have received treatment within the past 14 days
- Known brain metastases that are untreated, symptomatic or require therapy to control
symptoms
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ARQ197
- History of congestive heart failure, active coronary artery disease, uncontrolled
hypertension, myocardial infarction within 6 months
- Uncontrolled intercurrent illness
- HIV positive on combination antiretroviral therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the Activity of ARQ-197
Outcome Description:
Evaluate the activity of ARQ-197, as defined as by 6-month Progression Free Survival (PFS) in Participants with triple-negative metastatic breast cancer.
Outcome Time Frame:
Patients will be followed until disease progression
Safety Issue:
No
Principal Investigator
Sara Tolaney, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
12-017
NCT ID:
NCT01542996
Start Date:
April 2012
Completion Date:
Related Keywords:
- Breast Cancer
- Recurrent
- Metastatic
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
