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A Safety Study of SGN-LIV1A in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01969643
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: SGN-LIV1A Drug: Trastuzumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
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
Actual Study Start Date : October 22, 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: SGN-LIV1A Dose Escalation Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks

Experimental: SGN-LIV1A + 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
SGN-LIV1A will be given at the recommended dose (at or below the monotherapy MTD determined in the SGN-LIV1A dose escalation arm).
Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969643


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

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Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Phillip Garfin, MD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01969643     History of Changes
Other Study ID Numbers: SGNLVA-001
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 29, 2018

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