ARQ197 in Metastatic Triple-Negative Breast Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT01542996 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-017

 

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved ARQ 197 for use in patients, including patients with your type of cancer. ARQ 197 is a drug that has been shown to slow down tumor cell growth and motility signals, which affects movement. This drug has been used in other research studies and information from those studies suggests that ARQ 197 may help to treat your cancer. The purpose of this research study is to find out what effects ARQ 197 has on you and your cancer.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Faulkner Hospital

Overall PI:
Sara Tolaney, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Erica Mayer, MD, Dana-Farber Cancer Institute

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

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
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