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

Primary Purpose

Metastatic Pancreatic Cancer, Pancreatic Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IMMU-107
placebo
Gemcitabine
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring clivatuzumab tetraxetan, 90Y-clivatuzumab tetraxetan, IMMU-107

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner MD Anderson
  • City of Hope National Medical Center
  • Pacific Shores Medical Group
  • Cedars-Sinai Medical Center
  • Whittingham Cancer Center
  • Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
  • Baptist Cancer Institute
  • Cancer Specialists of North Florida
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • Illinois Cancer Specialists
  • Indiana University Health Goshen Center for Cancer Care
  • Indiana University Melvin and Bren Simon Cancer Center
  • Ashland-Bellefonte Cancer Center
  • University of Maryland Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Henry Ford Health System
  • Masonic Cancer Center, University of Minnesota
  • University of Mississippi Medical Center
  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
  • Comprehensive Cancer Centers of Nevada
  • Dartmouth Hitchcock Medical Center
  • New York Presbyterian Hospital/Weill Cornell Medical Center
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester Medical Center
  • Stony Brook University Medical Center
  • SUNY Upstate Medical University
  • University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center
  • The Ohio State University - Comprehensive Cancer Center
  • Stephenson Cancer Center
  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
  • University of Pennsylvania Abramson Cancer Center
  • Fox Chase Cancer Center
  • University of Pittsburgh Medical Center/Hillman Cancer Center
  • Center for Biomedical Research
  • University of Tennessee Medical Center, Cancer Institute
  • Mary Crowley Medical Research Center
  • Oncology Consultants
  • Texas Oncology - McAllen
  • Texas Oncology - Tyler
  • Virginia Oncology Associates
  • University of Washington
  • Virginia Mason Medical Center
  • Krankenhaus der Elisabethinen Linz
  • Medical University Vienna
  • University Hospital Leuven
  • Cancer Care Manitoba
  • Centre Hospitalier Université de Sherbrooke
  • ICO René Gauducheau
  • Institut Paoli-Calmettes
  • Institut Bergonie
  • Centre Léon Bérard Cancerologie Medicale
  • Institut Paoli-Calmettes
  • CRLC Val D'Aurelle
  • CRLC Val D'Aurelle
  • Hopital Cochin
  • Soroka Medical Center
  • Rambam Medical Center
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
  • Hospital Sant Joan de Reu
  • Hospital Vall D'Hebrón
  • Hospital Universitario Gregorio Marañón
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario La Paz
  • Centro Integral Oncologico Clara Campal
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A IMMU-107 and gemcitabine

Arm B Placebo and low dose gemcitabine

Arm Description

IMMU-107 and low dose gemcitabine

Placebo and low dose gemcitabine

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Overall survival
Objective tumor response
Progression free survival
Clinical benefit
quality of life will be assessed over 24 months using the FACT-hepatopancreatic form

Full Information

First Posted
September 26, 2013
Last Updated
August 12, 2021
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01956812
Brief Title
Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
Acronym
PANCRIT®-1
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
The DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo.
Study Start Date
December 2013 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer, Pancreatic Cancer
Keywords
clivatuzumab tetraxetan, 90Y-clivatuzumab tetraxetan, IMMU-107

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A IMMU-107 and gemcitabine
Arm Type
Experimental
Arm Description
IMMU-107 and low dose gemcitabine
Arm Title
Arm B Placebo and low dose gemcitabine
Arm Type
Active Comparator
Arm Description
Placebo and low dose gemcitabine
Intervention Type
Drug
Intervention Name(s)
IMMU-107
Other Intervention Name(s)
90Y-clivatuzumab tetraxetan
Intervention Description
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline
Intervention Description
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
gemcitabine 200 mg/m2
Intervention Description
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Primary Outcome Measure Information:
Title
overall survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3, 6 and 12 months
Title
Objective tumor response
Time Frame
24 months
Title
Progression free survival
Time Frame
24 months
Title
Clinical benefit
Description
quality of life will be assessed over 24 months using the FACT-hepatopancreatic form
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wegener, MD, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Banner MD Anderson
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Whittingham Cancer Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Indiana University Health Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ashland-Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New York Presbyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7007
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7510
Country
United States
Facility Name
The Ohio State University - Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Medical Center/Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Center for Biomedical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
University of Tennessee Medical Center, Cancer Institute
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cancer Care Manitoba
City
Winnepeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Centre Hospitalier Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
ICO René Gauducheau
City
Nantes
State/Province
Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
State/Province
Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Léon Bérard Cancerologie Medicale
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CRLC Val D'Aurelle
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
CRLC Val D'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Sant Joan de Reu
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Hospital Vall D'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22569804
Citation
Ocean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, Sung MW, Gulec SA, Goldsmith SJ, Manzone T, Holt M, O'Neil BH, Hall N, Montero AJ, Kauh J, Gold DV, Horne H, Wegener WA, Goldenberg DM. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.
Results Reference
background
PubMed Identifier
21527562
Citation
Gulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, Teoh N, Gold DV, Sharkey RM, Goldenberg DM. Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.
Results Reference
background
PubMed Identifier
21467164
Citation
Sharkey RM, Karacay H, Govindan SV, Goldenberg DM. Combination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human pancreatic carcinoma xenograft models. Mol Cancer Ther. 2011 Jun;10(6):1072-81. doi: 10.1158/1535-7163.MCT-11-0115. Epub 2011 Apr 5.
Results Reference
background
PubMed Identifier
22406590
Citation
Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62.
Results Reference
background
PubMed Identifier
24257318
Citation
Gold DV, Newsome G, Liu D, Goldenberg DM. Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin. Mol Cancer. 2013 Nov 20;12(1):143. doi: 10.1186/1476-4598-12-143.
Results Reference
background
PubMed Identifier
22898932
Citation
Gold DV, Gaedcke J, Ghadimi BM, Goggins M, Hruban RH, Liu M, Newsome G, Goldenberg DM. PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. Cancer. 2013 Feb 1;119(3):522-8. doi: 10.1002/cncr.27762. Epub 2012 Aug 16.
Results Reference
background
PubMed Identifier
20810605
Citation
Gold DV, Goggins M, Modrak DE, Newsome G, Liu M, Shi C, Hruban RH, Goldenberg DM. Detection of early-stage pancreatic adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2786-94. doi: 10.1158/1055-9965.EPI-10-0667. Epub 2010 Sep 1.
Results Reference
background
PubMed Identifier
18559529
Citation
Gold DV, Goldenberg DM, Karacay H, Rossi EA, Chang CH, Cardillo TM, McBride WJ, Sharkey RM. A novel bispecific, trivalent antibody construct for targeting pancreatic carcinoma. Cancer Res. 2008 Jun 15;68(12):4819-26. doi: 10.1158/0008-5472.CAN-08-0232.
Results Reference
background
PubMed Identifier
18094420
Citation
Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7. doi: 10.1158/1078-0432.CCR-07-1488.
Results Reference
background
PubMed Identifier
16344318
Citation
Gold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. doi: 10.1200/JCO.2005.02.8282. Epub 2005 Dec 12.
Results Reference
background
PubMed Identifier
14991585
Citation
Gold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26. doi: 10.1002/ijc.20004.
Results Reference
background
PubMed Identifier
14506191
Citation
Gold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S.
Results Reference
background
PubMed Identifier
11774294
Citation
Cardillo TM, Blumenthal R, Ying Z, Gold DV. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002 Jan 20;97(3):386-92. doi: 10.1002/ijc.1613.
Results Reference
background
PubMed Identifier
11595713
Citation
Cardillo TM, Ying Z, Gold DV. Therapeutic advantage of (90)yttrium- versus (131)iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001 Oct;7(10):3186-92.
Results Reference
background
PubMed Identifier
11418312
Citation
Gold DV, Cardillo T, Goldenberg DM, Sharkey RM. Localization of pancreatic cancer with radiolabeled monoclonal antibody PAM4. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):147-54. doi: 10.1016/s1040-8428(01)00114-7.
Results Reference
background
PubMed Identifier
9178823
Citation
Gold DV, Cardillo T, Vardi Y, Blumenthal R. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997 May 16;71(4):660-7. doi: 10.1002/(sici)1097-0215(19970516)71:43.0.co;2-e.
Results Reference
background
PubMed Identifier
7493369
Citation
Mariani G, Molea N, Bacciardi D, Boggi U, Fornaciari G, Campani D, Salvadori PA, Giulianotti PC, Mosca F, Gold DV, et al. Initial tumor targeting, biodistribution, and pharmacokinetic evaluation of the monoclonal antibody PAM4 in patients with pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5911s-5915s.
Results Reference
background
PubMed Identifier
7493339
Citation
Alisauskus R, Wong GY, Gold DV. Initial studies of monoclonal antibody PAM4 targeting to xenografted orthotopic pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5743s-5748s.
Results Reference
background
PubMed Identifier
7512537
Citation
Gold DV, Lew K, Maliniak R, Hernandez M, Cardillo T. Characterization of monoclonal antibody PAM4 reactive with a pancreatic cancer mucin. Int J Cancer. 1994 Apr 15;57(2):204-10. doi: 10.1002/ijc.2910570213.
Results Reference
background

Learn more about this trial

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

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