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A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

31. august 2015 opdateret af: Astellas Pharma Inc

A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.

Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to documented disease progression will be followed by telephone contact every 2 months until they begin a new anticancer therapy, their disease progresses, they die, become lost to follow-up or withdrawal consent for further follow-up, whichever of these events occurs first.

Overall survival: All subjects will be followed by telephone contact every 2 months until death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

205

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Den Russiske Føderation
      • Arkhangelsk, Den Russiske Føderation
        • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
      • Ivanovo, Den Russiske Føderation
        • Regional Oncology Dispensary
      • Kazan, Den Russiske Føderation
        • Clinical Oncology Dispensary of Republic of Tatarstan
      • Kuzmolovo, Den Russiske Føderation
        • State Healthcare Institution "Leningrad Regional Oncologic Dispensary"
      • Moscow, Den Russiske Føderation
        • Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"
      • Obninsk, Den Russiske Føderation
        • Medical Radiology Research Center of Russian Medical Academy
      • Omsk, Den Russiske Føderation
        • State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
      • Saint Petersburg, Den Russiske Føderation
        • State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
      • St. Petersburg, Den Russiske Føderation
        • Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"
  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92093
        • University of California San Diego Medical Center
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33435
        • Palm Beach Institute of Hematology and Oncology
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Medical Oncology LLC
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Annapolis Oncology Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana Farber Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia G. Piper Cancer Center
    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan Kettering Cancer Center
      • Syracuse, New York, Forenede Stater, 13210
        • Regional Oncology Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97227
        • Kaiser Permanente Northwest Region Oncology Hematology
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Baptist Regional Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center, Div. of Medical Oncology
    • Virginia
      • Lynchburg, Virginia, Forenede Stater, 24501
        • Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
  • Frankrig
      • Clermont-Ferrand, Frankrig
        • CHU Estaing
      • Le Mans Cedex, Frankrig
        • Centre Jean Bernard, Oncologie médicale
      • Lille, Frankrig
        • Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret
      • Pessac, Frankrig
        • Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie
      • Poitiers Cedex, Frankrig
        • Centre Hospitalier Universitaire de Poitiers
      • Rouen, Frankrig
        • Hôpital Charles Nicolle
  • Spanien
      • Barcelona, Spanien
        • Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
      • Madrid, Spanien
      • Toledo, Spanien
        • Hospital Virgen de la Salud, Servicio Oncologia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
  • Non-measurable or measurable disease based on the RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Life expectancy of > 3 months

  • Hematologic function, as follows:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 9 g/dL (transfusion independent)

  • Renal function, as follows:

    • Creatinine ≤ 2.0 mg/dL

  • Hepatic function, as follows:

    • Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases.
    • Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
    • Bilirubin ≤ 2 x ULN
  • INR < 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)

Exclusion Criteria:

  • Prior systemic therapy for metastatic pancreatic cancer

    • Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed
    • Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded
  • Chemotherapy and/or radiation within 4 weeks of study enrollment
  • Prior monoclonal antibody therapy within 60 days of study enrollment
  • Known brain or leptomeningeal disease

  • History of other primary malignancy, unless:

    • Curatively resected non-melanomatous skin cancer
    • Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
  • Use of any investigational product within 4 weeks of study enrollment
  • Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
  • Women who are pregnant (confirmed by positive pregnancy test) or lactating
  • Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
  • Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
  • Active serious infection not controlled with antibiotics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1. Gemcitabine monotherapy
Biologisk: Gemcitabine
IV infusion
Eksperimentel: 2. Gemcitabine plus AGS-1C4D4
Biologisk: Gemcitabine
IV infusion
Biologisk: AGS-1C4D4
IV infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Survival rate at 6 months
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Overall Survival (OS)
Tidsramme: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study
Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study
Progression free survival (PFS)
Tidsramme: Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study
Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study
Change in level of serum tumor marker CA 19-9
Tidsramme: Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period
Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period
Incidence of anti-AGS-1C4D4 antibody formation
Tidsramme: Week 1, Week 7 and every 8 weeks during the extended treatment period
Week 1, Week 7 and every 8 weeks during the extended treatment period
Objective Response Rate (Partial Response or better per RECIST criteria version 1.1
Tidsramme: Week 8, and every 8 weeks during the extended treatment period
Week 8, and every 8 weeks during the extended treatment period
Disease Control (Stable Disease or better per RECIST criteria)
Tidsramme: Week 8, and every 8 weeks during the extended treatment period
Week 8, and every 8 weeks during the extended treatment period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Astellas Pharma Inc

Samarbejdspartnere

Agensys, Inc.

Efterforskere

  • Studieleder: Chief Medical Officer, Agensys, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

13. maj 2009

Først indsendt, der opfyldte QC-kriterier

13. maj 2009

Først opslået (Skøn)

15. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2008002
  • 2009-009194-99 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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