A Phase 2, 2-Stage, 2-Cohort Study of BMN 673 Administered to Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer

This study is currently recruiting participants.
Verified March 2014 by BioMarin Pharmaceutical
Sponsor:
Collaborators:
Translational Research in Oncology
Myriad Genetics, Inc.
Information provided by (Responsible Party):
BioMarin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02034916
First received: January 9, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of BMN 673 in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

  • Cohort 1) Subjects who have previously responded to platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or
  • Cohort 2) Subjects who have received > 2 chemotherapy regimens and who have had no prior platinum therapy for metastatic disease

Condition Intervention Phase
Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Drug: BMN 673
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, 2-Stage, 2-Cohort Study of BMN 673 in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation

Resource links provided by NLM:


Further study details as provided by BioMarin Pharmaceutical:

Primary Outcome Measures:
  • Determine Objective Response Rate (ORR) for each cohort [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefit response (CBR) rate defined as CR + PR + SD lasting ≥ 24 weeks [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Health-related quality of life [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2014
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMN 673

Cohort 1) Subjects who have previously responded to a platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum

Cohort 2) Subjects who have received > 2 prior chemotherapy regimens and who have had no prior platinum therapy for metastatic disease

Drug: BMN 673

  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 carcinoma of the breast
  • Locally advanced and/or metastatic disease
  • Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation
  • Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
  • ECOG performance status ≤ 1
  • Have adequate organ function

Exclusion Criteria:

  • Prior enrollment into a clinical trial of a PARP inhibitor
  • CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms
  • Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study enrollment with no subsequent evidence of recurrence
  • Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus
  • Known hypersensitivity to any of the components of BMN 673
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02034916

Contacts
Contact: Eugenia Litz 415-506-6570 elitz@bmrn.com

Locations
United States, California
Marin Cancer Care, Inc. Recruiting
Greenbrae, California, United States, 94904
Contact: Jaime Chang, BS,CCRP    415-925-5040    jchang@marinspecialtycare.com   
Principal Investigator: Peter D. Eisenberg, MD         
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Shanna Overbey, B, RN    865-305-9773    soverbey@utmck.edu   
Principal Investigator: Timothy J. Panella, MD         
Sponsors and Collaborators
BioMarin Pharmaceutical
Translational Research in Oncology
Myriad Genetics, Inc.
  More Information

No publications provided

Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT02034916     History of Changes
Other Study ID Numbers: 673-201
Study First Received: January 9, 2014
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMarin Pharmaceutical:
Breast cancer
BRCA mutation
PARP inhibitor
BRCA 1
BRCA 2

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

ClinicalTrials.gov processed this record on April 17, 2014