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A Safety Study of SGN-LIV1A in Breast Cancer Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 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 8, 2017
Last verified: September 2017
  Purpose
This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. 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
Intervention Model: Parallel Assignment
Masking: None (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 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 ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures:
  • Blood concentrations of SGN-LIV1A and metabolites [ Time Frame: Through 3 weeks after dosing ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]
  • Objective response rate [ Time Frame: Through 1 month following last dose ]
  • Duration of response [ Time Frame: Up to approximately 3 years ]
  • Progression-free survival [ Time Frame: Up to approximately 3 years ]
  • Overall survival [ Time Frame: Up to approximately 3 years ]
  • Progression-free survival relative to prior therapy [ Time Frame: Up to approximately 3 years ]

Estimated Enrollment: 216
Study Start Date: September 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-LIV1A Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks
Experimental: SGN-LIV1A with Trastuzumab Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks
Drug: Trastuzumab
Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
Other Name: Herceptin
Experimental: SGN-LIV1A in Patients with Triple-Negative Breast Cancer Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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: Part A) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or 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 Part B) Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or Part C) Triple-negative disease and received up to 4 prior regimens (excluding hormonally directed/endocrine therapies), and at least 2 must have been given for incurable, unresectable LA/MBC.
  • Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • 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
  • 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

  Show 25 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Phillip Garfin, 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: September 8, 2017

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 September 25, 2017