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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 : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given alone or in combination with trastuzumab.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 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 : November 2020
Estimated Study Completion Date : October 2021

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)

Experimental: SGN-LIV1A + Trastuzumab Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV)

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)




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

Secondary Outcome Measures :
  1. Blood concentrations of SGN-LIV1A and metabolites [ Time Frame: Through 3 weeks after dosing; up to approximately 2 years ]
  2. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
  3. Objective response rate (ORR) [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
    ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.

  4. Duration of response (DOR) [ Time Frame: Up to approximately 3 years ]
    DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1).

  5. Progression-free survival (PFS) [ Time Frame: Up to approximately 8 years ]
    PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).

  6. Overall survival (OS) [ Time Frame: Up to approximately 8 years ]
    OS is defined as the time from start of study treatment to date of death due to any cause.

  7. PFS relative to prior therapy [ Time Frame: Up to approximately 8 years ]
    The PFS ratio is defined for each subject as the ratio of the current PFS and the PFS achieved on their most recent therapy where they experienced progression.



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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) HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
  • Parts A, B, C, and D: Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • Part E: Archival baseline tumor sample is required; a fresh biopsy sample may be submitted in place of an archival sample if medically feasible.
  • 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
  • Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Part E: Known or suspected cerebral/meningeal metastasis 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
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Erica Stringer-Reasor, MD         
United States, Arizona
Pinnacle Oncology Hematology Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Michael Gordon         
United States, California
UC San Diego / Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Sarah Boles         
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Monica Mita, MD         
UCLA Medical Center / David Geffen School of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Sara Hurvitz         
University of California at San Francisco Recruiting
San Francisco, California, United States, 94134
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Hope Rugo, MD         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Sami Diab         
xxx.Cancer Care & Hematology - Fort Collins Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Diana Medgyesy         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Lajos Pusztai, MD         
The Whittingham Cancer Center / Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Linda Vahdat, MD         
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Hyo Heather Han         
United States, Georgia
Piedmont Cancer Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Rajni Sinha         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Rita Nanda         
United States, Louisiana
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Agustin Garcia, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Katherine H. R. Tkaczuk         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Ian Krop, MD         
United States, Michigan
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Amy Weise, MD         
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Michaela Tsai         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Heather Beckwith, MD         
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Minetta Liu, MD         
United States, Missouri
Washington University in St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Foluso Ademuyiwa         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Ursa Brown-Glaberman         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Kevin Kalinsky         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Shanu Modi, MD         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Eleni Andreopoulou, MD         
United States, North Carolina
Wake Forest Baptist Medical Center / Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Lowell Hart, MD         
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Afshin Dowlati, PI         
Cleveland Clinic, The Recruiting
Cleveland, Ohio, United States, 44195
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Jame Abraham, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Zahi Mitri, MD         
United States, Tennessee
Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Howard Burris, MD         
United States, Texas
Texas Oncology - Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Joyce O'Shaughnessy         
Cancer Care Centers of South Texas - HOAST Recruiting
New Braunfels, Texas, United States, 78130
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Sharon Wilks         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Erin Ellis         
Seattle Cancer Care Alliance / University of Washington Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Jennifer Specht, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, United States
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Shalu Pahuja, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Phillip Garfin, MD Seattle Genetics, Inc.

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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: October 1, 2019
Last Verified: September 27, 2019
Keywords provided by Seattle Genetics, Inc.:
Breast cancer
Monomethyl auristatin E
Antibody-drug conjugate
Drug therapy
Metastatic
LIV-1 protein, human
Trastuzumab
Ladiratuzumab vedotin
hLIV22-vcMMAE
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Immunoconjugates
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs