Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
Conditions
Metastatic Pancreatic Cancer - Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
clivatuzumab tetraxetan, 90Y-clivatuzumab tetraxetan, IMMU-107
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: IMMU-107 Type: Drug
Name: placebo Type: Drug
Name: Gemcitabine Type: Drug
Overall Status
Recruiting
Summary
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Locations
City of Hope National Medical Center
Duarte, California, United States
Status: Recruiting
Contact: Carol Rose - 626-359-8111 - crose@coh.org
Pacific Shores Medical Group
Long Beach, California, United States
Status: Recruiting
Contact: Andre Liem - 562-590-0345 - andrel@pacshoresoncology.com
Cedars-Sinai Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Suzanne Swain-Brint - 310-967-4397 - suzanne.swaincabriales@cshs.org
Whittingham Cancer Center
Norwalk, Connecticut, United States
Status: Recruiting
Contact: Patricia Glynn - 203-852-3012 - patricia.glynn@norwalkhealth.org
Baptist Cancer Institute
Jacksonville, Florida, United States
Status: Recruiting
Contact: Jeanine Richmond - 904-202-7070 - jeanine.richmond@bmcjax.com
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Status: Recruiting
Contact: Melissa Rammage - 904-519-2731 - melissa.rammage@csnf.us
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Status: Recruiting
Contact: Diana McDonaugh - 208-381-3376 - mcdonagd@slhs.org
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Status: Recruiting
Contact: Heather Lee - 847-259-0624 - heather.lee@usoncology.com
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States
Status: Recruiting
Contact: Pat Vandenburg - 574-364-2974 - pvandenburg@iuhealth.org
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Lynne McCranor - 317-278-4712 - lmccrano@iupui.edu
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Recruiting
Contact: Colette Zack - 313-576-9385 - zackc@karmanos.org
Henry Ford Health System
Detroit, Michigan, United States
Status: Recruiting
Contact: Mary Hewson - 313-916-1784 - mhewson1@hfhs.org
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Carrie McCann - 612-626-2569 - mcca0313@umn.edu
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Status: Recruiting
Contact: Faye Park - fpark@nebraskacancer.com
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Joyce Pekkattil - Joyson.Pekkattil@USONCOLOGY.COM
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Susan Tarczewski - 603-650-6380 - susan.m.tarczewski@hitchcock.org
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Joseph Crotty - 646-888-4329 - crottyj@mskcc.org
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Status: Recruiting
Contact: Amanda De Laurentiis - 646-962-9349 - amd9041@med.cornell.edu
University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Julie White, RN, OCN - 919-843-7115 - julie_white@med.unc.edu
The Ohio State University - Comprehensive Cancer Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Sanaa Tahiri - 614-293-5894 - sanaa.tahiri@osumc.edu
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Melissa Yarbrough - 405-271-8001 - melissa-yarbrough@ouhsc.edu
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Status: Recruiting
Contact: Anna St. Pierre - 717-531-0003 - astpierre@hmc.psu.edu
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Rebecca Marlow - 215-214-1451 - becky.marlow@fccc.edu
University of Pittsburgh Medical Center/Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Andrea Fabian, RN, CRC - 412-235-1317 - fabiana@upmc.edu
Center for Biomedical Research
Knoxville, Tennessee, United States
Status: Recruiting
Contact: Kristi Simcox - 865-934-2675 - ksimcox@biomed-research.com
University of Tennessee Medical Center, Cancer Institute
Knoxville, Tennessee, United States
Status: Recruiting
Contact: Shana Overby, RN, BSN - 865-305-9773 - SOverbey@mc.utmck.edu
Mary Crowley Medical Research Center
Dallas, Texas, United States
Status: Recruiting
Contact: Keisha Riser - 972-566-3066 - kriser@marycrawley.org
Oncology Consultants
Houston, Texas, United States
Status: Recruiting
Contact: Lafit Ramos - 713-516-4968 - lramos@oncologyconsultants.com
Virginia Oncology Associates
Norfolk, Virginia, United States
Status: Recruiting
Contact: Wendi Gobhart - 757-213-5813 - Wendi.Gobhardt@USONCOLOGY.COM
Virginia Mason Medical Center
Seattle, Washington, United States
Status: Recruiting
Contact: Leila Ponce - 206-342-6926 - Leila.Ponce@vmmc.org
Krankenhaus der Elisabethinen Linz
Linz, Austria
Status: Recruiting
Contact: Silvia Hoefler - +43 732 7676 4412 - Silvia.Hoefler@elisabethinen.or.at
Medical University Vienna
Vienna, Austria
Status: Recruiting
Contact: Ruth Stromberger - +43-1-40400-69340 - ruth-sonja.stromberger@meduniwien.ac.at
University Hospital Leuven
Leuven, Belgium
Status: Recruiting
Contact: Nathalie Devolder - 0032 16 34 13 16 - nathalie.devolder@uzleuven.be
Cancer Care Manitoba
Winnepeg, Manitoba, Canada
Status: Recruiting
Contact: Elizabeth Lylyk - 204-787-1199 - Elylyk@cancercare.mb.ca
Centre Hospitalier Université de Sherbrooke
Sherbrooke, Quebec, Canada
Status: Recruiting
Contact: Rodrigue Marc-Andre - 819-346-1110 - marodrigue.chus@ssss.gouv.qc.ca
Rambam Medical Center
Haifa, Israel
Status: Recruiting
Contact: Marina Gurman - 972 (4) 854-3812 - m_gurman@rambam.health.gov.il
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
Warszawa, Poland
Status: Recruiting
Contact: Joanna Dlugosinska - +48 225462041 - joannadlugosinska@wp.pl
Hospital Sant Joan de Reu
Reus, Tarragona, Spain
Status: Recruiting
Contact: Dolors Salsench - 664300708 - mdsalsench@grupsagessa.com
Hospital Vall D'Hebrón
Barcelona, Spain
Status: Recruiting
Contact: Iratxe Puebla - 0034 93 489 4374 - ipuebla@vhebron.net
Centro Integral Oncologico Clara Campal
Madrid, Spain
Status: Recruiting
Contact: Gemma Sanchez - 0034 91 756 78 00 - gsanchez@fundacionhm.com
Hospital Universitario Gregorio Marañón
Madrid, Spain
Status: Recruiting
Contact: Ignacio Ruiz - 34 91 426 93 94
Hospital Universitario La Paz
Madrid, Spain
Status: Recruiting
Contact: Pilar Boyero - 0034 91 727 75 16 - pilarboyero@gmail.com
Hospital Universitario Ramon y Cajal
Madrid, Spain
Status: Recruiting
Contact: Ricardo Rebaque - rebaquejimenez@gmail.com
Hospital Miguel Servet
Zaragoza, Spain
Status: Recruiting
Contact: Laura Rodriguez Sastre - +34 976765500 ext 3825 - lrsastre70@gmail.com
Start Date
January 2014
Completion Date
October 2015
Sponsors
Immunomedics, Inc.
Source
Immunomedics, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page