A Safety Study of SGN-LIV1A in Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01969643
First received: October 21, 2013
Last updated: July 28, 2016
Last verified: May 2016
  Purpose
This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. Increasing doses of SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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: 216
Study Start Date: September 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy SGN-LIV1A Drug: SGN-LIV1A
by intravenous infusion every 3 weeks
Experimental: Combination Therapy SGN-LIV1A with Trastuzumab Drug: SGN-LIV1A
by intravenous infusion every 3 weeks
Drug: Trastuzumab
6 mg/kg by intravenous infusion every 3 weeks (subsequent to an initial loading dose of 8 mg/kg administered in the first cycle)
Other Name: Herceptin

Detailed Description:
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. This study will examine the safety profile of SGN-LIV1A administered as a single agent and in combination with trastuzumab for patients with HER2-positive disease.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
  • One of the following: a) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or b) ER- and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy; or c) Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting.
  • 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
  • Combination Arm: adequate heart function

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
  • Combination Arm: hypersensitivity to trastuzumab
  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: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Kimberly LaMaster    205-934-5367    lamaster@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, California
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Virginia Naessig    310-423-0721    Virginia.naessig@cshs.org   
Principal Investigator: Monica Mita, MD         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 6520
Contact: Noelle Sowers    203-737-3472    noelle.sowers@yale.edu   
Principal Investigator: Lajos Pusztai, MD         
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Suzanne Bailey    317-274-0933    subailey@iupui.edu   
Principal Investigator: Kathy Miller, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Anna Pereira    617-632-6651    annac_pereira@dfci.harvard.edu   
Principal Investigator: Ian Krop, 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, MD         
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michelle Roos    507-538-7036    roos.michelle@mayo.edu   
Principal Investigator: Minetta Liu, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Shaina Joseph    646-888-5332    josephs2@mskcc.org   
Principal Investigator: Shanu Modi, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 30384
Contact: Heather Pedigo    615-329-7274    Heather.Pedigo@scresearch.net   
Principal Investigator: Howard Burris, MD         
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, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Ana Kostic, MD Seattle Genetics, Inc.
  More Information

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: July 28, 2016
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
Trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Immunoconjugates
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016