Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic CancerPancreatic Cancer
- Interventions
- Registration Number
- NCT01956812
- Lead Sponsor
- Gilead Sciences
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 334
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A IMMU-107 and gemcitabine IMMU-107 IMMU-107 and low dose gemcitabine Arm B Placebo and low dose gemcitabine placebo Placebo and low dose gemcitabine Arm A IMMU-107 and gemcitabine Gemcitabine IMMU-107 and low dose gemcitabine Arm B Placebo and low dose gemcitabine Gemcitabine Placebo and low dose gemcitabine
- Primary Outcome Measures
Name Time Method overall survival 24 months
- Secondary Outcome Measures
Name Time Method Objective tumor response 24 months Clinical benefit 24 months quality of life will be assessed over 24 months using the FACT-hepatopancreatic form
Overall survival 3, 6 and 12 months Progression free survival 24 months
Trial Locations
- Locations (63)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center/Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
The Ohio State University - Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Masonic Cancer Center, University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Austria
Institut Bergonie
🇫🇷Bordeaux, Cedex, France
Centre Hospitalier Université de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
CRLC Val D'Aurelle
🇫🇷Montpellier, France
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Institut Paoli-Calmettes
🇫🇷Marseille, France
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Centre Léon Bérard Cancerologie Medicale
🇫🇷Lyon, France
Hopital Cochin
🇫🇷Paris, France
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Vall D'Hebrón
🇪🇸Barcelona, Spain
Rambam Medical Center
🇮🇱Haifa, Israel
Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Banner MD Anderson
🇺🇸Gilbert, Arizona, United States
Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Indiana University Health Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
Ashland-Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Soroka Medical Center
🇮🇱Beer Sheva, Israel
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Center for Biomedical Research
🇺🇸Knoxville, Tennessee, United States
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
University of Tennessee Medical Center, Cancer Institute
🇺🇸Knoxville, Tennessee, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
University Hospital Leuven
🇧🇪Leuven, Belgium
Cancer Care Manitoba
🇨🇦Winnepeg, Manitoba, Canada
ICO René Gauducheau
🇫🇷Nantes, Cedex 1, France
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
🇵🇱Warszawa, Poland
Hospital Sant Joan de Reu
🇪🇸Reus, Tarragona, Spain
Medical University Vienna
🇦🇹Vienna, Austria
City of Hope National Medical Center
🇺🇸Duarte, California, United States