ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    SGN | Breast Cancer
Previous Study | Return to List | Next Study

A Safety Study of SGN-LIV1A in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01969643
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

October 21, 2013
October 25, 2013
February 4, 2019
October 22, 2013
July 2019   (Final data collection date for primary outcome measure)
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
Same as current
Complete list of historical versions of study NCT01969643 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Progression-free survival relative to prior therapy [ Time Frame: Up to approximately 3 years ]
Not Provided
Not Provided
 
A Safety Study of SGN-LIV1A in Breast Cancer Patients
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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 Dose Escalation
    Intervention: Drug: SGN-LIV1A
  • Experimental: SGN-LIV1A + Trastuzumab
    Interventions:
    • Drug: SGN-LIV1A
    • Drug: Trastuzumab
  • Experimental: SGN-LIV1A
    SGN-LIV1A will be given at the recommended dose (at or below the monotherapy MTD determined in the SGN-LIV1A dose escalation arm).
    Intervention: Drug: SGN-LIV1A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
306
51
July 2020
July 2019   (Final data collection date for primary outcome measure)

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-positive 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 (not enrolling new patients);
    • Part B) Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
    • Part C) Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
    • Part D) Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
    • Part E) ER-positive and/or PR-positive/HER2- disease and received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting.
  • 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
  • Prior treatment with SGN-LIV1A or prior treatment with an MMAE-containing therapy
  • Combination Arm: hypersensitivity to trastuzumab
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com
United States
 
 
NCT01969643
SGNLVA-001
No
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Phillip Garfin, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
January 31, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP