ARQ197 in Metastatic Triple-Negative Breast Cancer

Status:	Recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/23/2013
Start Date:	April 2012
Contact:	Sara Tolaney, MD
Email:	stolaney@partners.org
Phone:	6176323800

A Phase 2 Study of ARQ 197 in Metastatic Triple-Negative Breast Cancer

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.

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

We found this trial at

sites

Brigham and Women's Hosp

75 Francis street
Boston, Massachusetts 02115

(617) 732-5500