Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer (PANCRIT®-1)

August 12, 2021 updated by: Gilead Sciences

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, A-4020
        • Krankenhaus der Elisabethinen Linz
      • Vienna, Austria, 1090
        • Medical University Vienna
  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven
  • Canada
    • Manitoba
      • Winnepeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universite de Sherbrooke
  • France
      • Lyon, France, 69008
        • Centre Léon Bérard Cancerologie Medicale
      • Marseille, France, 13273
        • Institut Paoli-Calmettes
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle
      • Montpellier Cedex 5, France, 34298
        • CRLC Val d'Aurelle
      • Paris, France, 75014
        • Hopital Cochin
    • Cedex
      • Bordeaux, Cedex, France, 33076
        • Institut Bergonié
    • Cedex 1
      • Nantes, Cedex 1, France, 44093
        • ICO René Gauducheau
    • Cedex 9
      • Marseille, Cedex 9, France, 13273
        • Institut Paoli-Calmettes
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Center
  • Poland
      • Warszawa, Poland, 02-781
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28050
        • Centro Integral Oncológico Clara Campal
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Sant Joan de Reu
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Indiana University Health Goshen Center for Cancer Care
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Ashland-Bellefonte Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • University of Mississippi Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital/Weill Cornell Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794-7007
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7510
        • University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University - Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center/Hillman Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Center for Biomedical Research
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center, Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75251
        • Mary Crowley Medical Research Center
      • Houston, Texas, United States, 77030
        • Oncology Consultants
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington
      • Seattle, Washington, United States, 98111
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A IMMU-107 and gemcitabine
IMMU-107 and low dose gemcitabine
Drug: IMMU-107
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
Other Names:
  • 90Y-clivatuzumab tetraxetan
Drug: Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Other Names:
  • gemcitabine 200 mg/m2
ACTIVE_COMPARATOR: Arm B Placebo and low dose gemcitabine
Placebo and low dose gemcitabine
Drug: Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Other Names:
  • gemcitabine 200 mg/m2
Drug: placebo
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective tumor response
Time Frame: 24 months
24 months
Progression free survival
Time Frame: 24 months
24 months
Overall survival
Time Frame: 3, 6 and 12 months
3, 6 and 12 months
Clinical benefit
Time Frame: 24 months
quality of life will be assessed over 24 months using the FACT-hepatopancreatic form
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2013

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMU-107-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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