A Safety Study of SGN-LIV1A in Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01969643
First received: October 21, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This study is being conducted to examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer, and to find the highest dose of the drug that can be given without unacceptable side effects. Other goals of the trial are to find out if SGN-LIV1A has any antitumor effects, to learn about the pharmacokinetics of SGN-LIV1A, and to explore the relationship between antigen expression and SGN-LIV1A effects.


Condition Intervention Phase
Breast Cancer
Drug: SGN-LIV1A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood concentrations of SGN-LIV1A and metabolites [ Time Frame: Through 3 weeks after dosing ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival relative to prior therapy [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: September 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-LIV1A
SGN-LIV1A every 3 weeks by intravenous infusion
Drug: SGN-LIV1A
by intravenous infusion every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of metastatic disease
  • One of the following: a) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the metastatic setting; or b) ER- and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the metastatic setting and are no longer a candidate for hormonal therapy
  • Positive for LIV-1 expression by central pathology review on archival or newly obtained tumor tissue biopsy
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1

Exclusion Criteria:

  • Pre-existing neuropathy Grade 2 or higher
  • Malignant CNS disease that has not been definitively treated
  • P-gp inducers/inhibitors or strong CYP3A inducers/inhibitors within 2 weeks before first dose
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969643

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Deborah Martin    205-975-3198    djmartin@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, California
Cedars-Sinai Medical Center / Samuel Oschin Comprehensive Cnacer Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Virginia Naessig    310-423-0721    virginia.naessig@cshs.org   
Principal Investigator: Monica Mita, M.D.         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Noelle Sowers    203-785-2068    noelle.sowers@yale.edu   
Principal Investigator: Lajos Pusztai         
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Merih Bennett    317-278-5160    mtzeggai@iupui.edu   
Principal Investigator: Kathy Miller, MD         
United States, Michigan
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Clarice Zuccaro    313-576-9375    zuccaroc@karmanos.org   
Principal Investigator: Amy Weise, D.O.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michelle Roos    507-538-7036    roos.michelle@mayo.edu   
Principal Investigator: Minetta Liu, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Hong-Ching Yeung    646-888-5072    yeungh@mskcc.org   
Principal Investigator: Shanu Modi, M.D.         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Heather Pedigo    615-329-7432    heather.pedigo@scresearch.net   
Principal Investigator: Howard Burris III         
United States, Washington
Seattle Cancer Care Alliance / University of Washington Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Audrey Mesher    206-288-2056    mollerup@u.washington.edu   
Principal Investigator: Jennifer Specht, M.D.         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Ana Kostic, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01969643     History of Changes
Other Study ID Numbers: SGNLVA-001
Study First Received: October 21, 2013
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Breast cancer
Monomethyl auristatin E
Antibody-drug conjugate
Drug therapy
Metastatic
LIV-1 protein, human

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

ClinicalTrials.gov processed this record on September 16, 2014