Clinical trial NCT01956812: Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Pancreatic Cancer
Pancreatic Cancer
Keywords: clivatuzumab tetraxetan
90Y-clivatuzumab tetraxetan
IMMU-107
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: overall survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 3, 6 and 12 months
measure: Objective tumor response
timeFrame: 24 months
measure: Progression free survival
timeFrame: 24 months
measure: Clinical benefit
timeFrame: 24 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Norwalk
country: United States
facility: Whittingham Cancer Center
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Boise
country: United States
facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center
state: Idaho
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Goshen
country: United States
facility: Indiana University Health Goshen Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Ashland
country: United States
facility: Ashland-Bellefonte Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: New York Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University - Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Hershey
country: United States
facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center/Hillman Cancer Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Center for Biomedical Research
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center, Cancer Institute
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz
city: Vienna
country: Austria
facility: Medical University Vienna
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Winnepeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Université de Sherbrooke
state: Quebec
city: Nantes
country: France
facility: ICO René Gauducheau
state: Cedex 1
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Cedex 9
city: Bordeaux
country: France
facility: Institut Bergonie
state: Cedex
city: Lyon
country: France
facility: Centre Léon Bérard Cancerologie Medicale
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier Cedex 5
country: France
facility: CRLC Val D'Aurelle
city: Montpellier
country: France
facility: CRLC Val D'Aurelle
city: Paris
country: France
facility: Hopital Cochin
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
city: Reus
country: Spain
facility: Hospital Sant Joan de Reu
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebrón
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Gilead Sciences
name: William Wegener, MD, PhD
role: STUDY_CHAIR
References:
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