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Metastatic Pancreatic CancerPhase 3PANCRIT®-1NCT01956812

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

A Phase 3 study testing IMMU-107 and Gemcitabine in people with Metastatic Pancreatic Cancer and Pancreatic Cancer, run by Gilead Sciences at 64 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMMU-107 and Gemcitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
64 sitesin 8 countries
Study dates
Dec 2013to Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

64 sites in 8 countries.

64 sites in 8 countries

United States42 sites

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Ashland-Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599-7510

  • The Ohio State University - Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75251

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Banner MD Anderson

    Gilbert, Arizona, 85234

  • Indiana University Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Oncology Consultants

    Houston, Texas, 77030

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39213

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Center for Biomedical Research

    Knoxville, Tennessee, 37909

  • University of Tennessee Medical Center, Cancer Institute

    Knoxville, Tennessee, 37920

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Whittingham Cancer Center

    Norwalk, Connecticut, 06856

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Medical Center/Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Washington

    Seattle, Washington, 98109

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-7007

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

Other trials in United States

France7 sites

  • Institut Bergonie

    Bordeaux, Cedex, 33076

  • Centre Léon Bérard Cancerologie Medicale

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, Cedex 9, 13273

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CRLC Val D'Aurelle

    Montpellier, 34298

  • ICO René Gauducheau

    Nantes, Cedex 1, 44093

  • Hopital Cochin

    Paris, 75014

Other trials in France

Spain7 sites

  • Hospital Vall D'Hebrón

    Barcelona, 08035

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Sant Joan de Reu

    Reus, Tarragona, 43204

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Austria2 sites

  • Krankenhaus der Elisabethinen Linz

    Linz, A-4020

  • Medical University Vienna

    Vienna, 1090

Other trials in Austria

Canada2 sites

  • Centre Hospitalier Université de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Cancer Care Manitoba

    Winnepeg, Manitoba, R3E 0V9

Other trials in Canada

Israel2 sites

  • Soroka Medical Center

    Beersheba, 84101

  • Rambam Medical Center

    Haifa, 3109601

Other trials in Israel

Belgium1 site

  • University Hospital Leuven

    Leuven, 3000

Other trials in Belgium

Poland1 site

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa

    Warsaw, 02-781

Other trials in Poland

About this study

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)

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).

Being tested
IMMU-107, placebo, Gemcitabine
Keywords
clivatuzumab tetraxetan, 90Y-clivatuzumab tetraxetan, IMMU-107
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMMU-107Drug

    Also called 90Y-clivatuzumab tetraxetan

    Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles

  • placeboDrug

    Also called normal saline

    placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles

  • GemcitabineDrug

    Also called gemcitabine 200 mg/m2

    Gemcitabine, 200 mg/m2, given weekly x 4 in both arms

Study groups in NCT01956812
Study groupRoleWhat they receive
Arm A IMMU-107 and gemcitabineExperimentalIMMU-107 and low dose gemcitabine
Receives: Drug: IMMU-107; Drug: Gemcitabine
Arm B Placebo and low dose gemcitabineActive comparatorPlacebo and low dose gemcitabine
Receives: Drug: placebo; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 24 months

Secondary outcomes (4)

  1. Overall survival

    Measured: 3, 6 and 12 months

  2. Objective tumor response

    Measured: 24 months

  3. Progression free survival

    Measured: 24 months

  4. Clinical benefit

    quality of life will be assessed over 24 months using the FACT-hepatopancreatic form

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01956812
Sponsor's protocol ID
IMMU-107-04
Acronym
PANCRIT®-1
Status last verified
Mar 2020
First submitted
26 Sep 2013
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22569804

  • 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.

    PubMed 21527562

  • 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.

    PubMed 21467164

  • Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62.

    PubMed 22406590

  • 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.

    PubMed 24257318

  • 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.

    PubMed 22898932

  • 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.

    PubMed 20810605

  • 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.

    PubMed 18559529

  • 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.

    PubMed 18094420

  • 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.

    PubMed 16344318

  • 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.

    PubMed 14991585

  • 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.

    PubMed 14506191

  • 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.

    PubMed 11774294

  • 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.

    PubMed 11595713

  • 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.

    PubMed 11418312

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMMU-107 and Gemcitabine in people with Metastatic Pancreatic Cancer and Pancreatic Cancer, run by Gilead Sciences at 64 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, France, Spain, Austria, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01956812, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.

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