Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer



Status:Terminated
Conditions:Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2014
End Date:March 2017

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An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose
gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer
patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which
was a gemcitabine-containing regimen).


Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Metastatic disease

- Received at least two prior systemic cytotoxic chemotherapy regimens for
unresectable, locally advanced or metastatic disease.

- At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable,
locally advanced or metastatic disease must have contained gemcitabine and have met
the following criteria:

- Completed at least one cycle of the treatment

- Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the
first cycle of treatment

- Progressed while receiving this gemcitabine regimen or within 3 months of completing
gemcitabine

- Progression was documented,

- Preferentially radiologically by tumor growth or new lesions, or by

- Clear symptomatic deterioration supported by at least two of the following clinical
criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or
fatigue; progressive weight loss; new/worsening pain requiring increased pain
medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or
pleural effusions; other physical or laboratory findings consistent with disease
progression.

- KPS >/= 70

- Adequate bone marrow function

- Adequate hepatic function

- Adequate renal function

Exclusion Criteria:

- CNS metastatic disease

- Bulky disease (any single mass >10 cm).

->Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.

- Prior external beam irradiation to a field that includes more than 30% of the red
bone marrow.

- Patients with clinically significant severe cardiorespiratory disease.

Please consult with the clinical trial site for the full detailed list of specific
inclusion/exclusion criteria.
We found this trial at
43
sites
1276
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Omaha, NE
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
609
mi
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Detroit, MI
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
1251
mi
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Jackson, MS
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
2588
mi
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Los Angeles, CA
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
1117
mi
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Minneapolis, MN
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
335
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Rochester, NY
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
2483
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Seattle, WA
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Arlington Heights, Illinois 60005
862
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Arlington Heights, IL
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Ashland, Kentucky 41101
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Ashland, KY
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
357
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Baltimore, MD
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2248
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Boise, ID
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616
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Chapel Hill, NC
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640
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Columbus, OH
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Dallas, TX
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Detroit, Michigan 48202
610
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Detroit, MI
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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1228
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Ft. Lauderdale, FL
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Gilbert, Arizona 85234
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Gilbert, AZ
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757
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Goshen, IN
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Hershey, PA
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Houston, Texas 77203
1601
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Houston, TX
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
802
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Indianapolis, IN
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Jacksonville, Florida
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Jacksonville, FL
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Jacksonville, Florida 32256
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Jacksonville, FL
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Knoxville, Tennessee 37909
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Knoxville, TN
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815
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Knoxville, TN
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Linz,
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Long Beach, California 90813
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Long Beach, CA
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McAllen, Texas 78503
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McAllen, TX
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184
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
184
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New York, NY
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
467
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Norfolk, VA
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Norwalk, Connecticut 06851
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Norwalk, CT
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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475
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Pittsburgh, PA
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
2483
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Seattle, WA
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
127
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Stony Brook, NY
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750 East Adams Street
Syracuse, New York 13210
260
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Syracuse, NY
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Tyler, Texas 75702
1490
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Tyler, TX
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