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ARQ197 in Metastatic Triple-Negative Breast Cancer

This study is currently recruiting participants.
Verified March 2013 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Sara Tolaney, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01542996
First received: February 27, 2012
Last updated: April 24, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: ARQ 197
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ARQ 197 in Metastatic Triple-Negative Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Evaluate the Activity of ARQ-197 [ Time Frame: Patients will be followed until disease progression ] [ Designated as safety issue: No ]
    Evaluate the activity of ARQ-197, as defined as by 6-month Progression Free Survival (PFS) in Participants with triple-negative metastatic breast cancer.


Secondary Outcome Measures:
  • Objective Response Based on RECIST [ Time Frame: Patients will be followed until disease progression ] [ Designated as safety issue: No ]
    To evaluate objective response based on RECIST 1.1 criteria

  • Evaluate c-Met [ Time Frame: Will be done on archival tumor tissue ] [ Designated as safety issue: No ]
    To evaluate c-Met and phosph c-Met expression in archival tumor tissue

  • Evaluate Incidence of c-Met Positive Circulating Tumor Cells [ Time Frame: Will be done on baseline blood sample ] [ Designated as safety issue: No ]
    To evaluate the incidence of c-Met positive circulating tumor cells at baseline

  • Effect of ARQ 197 on Serum Markers [ Time Frame: Will be done on blood samples obtained at the start of each cycle of therapy ] [ Designated as safety issue: No ]
    Evaluate the effect of ARQ-197 on serum markers relevant to c-Met pathway

  • Proportion of Patients with Basal-like Breast Cancer [ Time Frame: Will be done on archival tumor tissue ] [ Designated as safety issue: No ]
    Evaluate the proportion of patients with basal-like breast cancer


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197
ARQ 197
 Drug: ARQ 197
360 mg po bid 21 day cycle

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542996

Contacts
Contact: Sara Tolaney, MD 6176323800 stolaney@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sara Tolaney, MD     617-632-3800     stolaney@partners.org    
Principal Investigator: Sara Tolaney, MD            
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sara Tolaney, MD     617-632-3800     stolaney@partners.org    
Principal Investigator: Sara Tolaney, MD            
Dana-Farber Cancer Institute at Faulkner Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Erica Mayer, MD     617-632-2335     emayer@partners.org    
Principal Investigator: Erica Mayer, MD            
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Sara Tolaney, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Sara Tolaney, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01542996     History of Changes
Other Study ID Numbers: 12-017
Study First Received: February 27, 2012
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Recurrent
Metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013