A Safety Study of SGN-LIV1A in Breast Cancer Patients



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 22, 2013
End Date:June 2021
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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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 (ladiratuzumab vedotin) in
patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in
combination with trastuzumab.


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
We found this trial at
37
sites
New York, New York 10021
Principal Investigator: Eleni Andreopoulou, MD
Phone: 866-333-7436
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Ursa Brown-Glaberman
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Erica Stringer-Reasor, MD
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Rita Nanda
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Heather Beckwith, MD
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Zahi Mitri, MD
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Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Hyo Heather Han
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H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Atlanta, Georgia 30318
Principal Investigator: Rajni Sinha
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Aurora, Colorado 80012
Principal Investigator: Sami Diab
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Katherine H. R. Tkaczuk
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ian Krop, MD
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Cleveland, Ohio 44106
Principal Investigator: Afshin Dowlati, PI
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Cleveland, Ohio 44195
Principal Investigator: Jame Abraham, MD
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Dallas, Texas 75246
Principal Investigator: Joyce O'Shaughnessy
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Detroit, Michigan
Principal Investigator: Amy Weise, MD
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Fort Collins, Colorado 80528
Principal Investigator: Diana Medgyesy
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Indianapolis, Indiana 46202
Principal Investigator: Kathy Miller, MD
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: Sarah Boles
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UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Fadi Braiteh
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Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Los Angeles, California 90048
Principal Investigator: Monica Mita, MD
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757 Westwood Plaza
Los Angeles, California 90095
Principal Investigator: Sara Hurvitz
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Minneapolis, Minnesota 55408
Principal Investigator: Michaela Tsai
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Shalu Pahuja, MD
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Howard Burris, MD
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Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Braunfels, Texas 78130
Principal Investigator: Sharon Wilks
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Lajos Pusztai, MD
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Orleans, Louisiana 70112
Principal Investigator: Agustin Garcia, MD
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Shanu Modi, MD
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Kevin Kalinsky
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Norwalk, Connecticut 06856
Principal Investigator: Linda Vahdat, MD
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Rochester, Minnesota 55905
Principal Investigator: Minetta Liu, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
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Scottsdale, Arizona 85258
Principal Investigator: Michael Gordon
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Seattle, Washington 98109
Principal Investigator: Jennifer Specht, MD
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Seattle, Washington 98104
Principal Investigator: Erin Ellis
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Winston-Salem, North Carolina 27157
Principal Investigator: Lowell Hart, MD
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