Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
NCT ID: NCT01956812
Last Updated: 2021-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
334 participants
INTERVENTIONAL
2013-12-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A IMMU-107 and gemcitabine
IMMU-107 and low dose gemcitabine
IMMU-107
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Arm B Placebo and low dose gemcitabine
Placebo and low dose gemcitabine
placebo
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Interventions
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IMMU-107
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
placebo
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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William Wegener, MD, PhD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Banner MD Anderson
Gilbert, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Whittingham Cancer Center
Norwalk, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital
Fort Lauderdale, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, 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
The Ohio State University - Comprehensive Cancer Center
Columbus, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center/Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Center for Biomedical Research
Knoxville, Tennessee, United States
University of Tennessee Medical Center, Cancer Institute
Knoxville, Tennessee, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Krankenhaus der Elisabethinen Linz
Linz, , Austria
Medical University Vienna
Vienna, , Austria
University Hospital Leuven
Leuven, , Belgium
Cancer Care Manitoba
Winnepeg, Manitoba, Canada
Centre Hospitalier Université de Sherbrooke
Sherbrooke, Quebec, Canada
ICO René Gauducheau
Nantes, Cedex 1, France
Institut Paoli-Calmettes
Marseille, Cedex 9, France
Institut Bergonie
Bordeaux, Cedex, France
Centre Léon Bérard Cancerologie Medicale
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
CRLC Val D'Aurelle
Montpellier, , France
Hopital Cochin
Paris, , France
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa
Warsaw, , Poland
Hospital Sant Joan de Reu
Reus, Tarragona, Spain
Hospital Vall D'Hebrón
Barcelona, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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References
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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.
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.
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.
Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IMMU-107-04
Identifier Type: -
Identifier Source: org_study_id
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