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A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

12. marts 2014 opdateret af: Clovis Oncology, Inc.

A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.

The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

367

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Córdoba, Argentina, X5004FHP
        • Clinica Universitaria Reina Fabiola
      • Santa Fe, Argentina, S3000FFU
        • ISIS Centro especializado
    • Bahia Blanca
      • Buenos Aires, Bahia Blanca, Argentina, B8000FJI
        • Policlínica Privada Instituto de Medicina Nuclear
    • Buenos Aires
      • Cuidad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Instituto Especializado Alexander Fleming
      • Loma Hermosa, Buenos Aires, Argentina, B1657BHD
        • Hospital de Gastroenterología
  • Australien
    • New South Wales
      • New Lambton Heights, New South Wales, Australien, 2305
        • Newcastle Private Hospital
      • Port Macquarie, New South Wales, Australien, 2444
        • Port Macquarie Base Hospital
      • Wollongong, New South Wales, Australien, 2500
        • Southern Medical Day Oncology Care Centre
    • South Australia
      • Bedford Park, South Australia, Australien, 5042
        • Flinders Medical Centre
    • Victoria
      • Fitzroy, Victoria, Australien, 3065
        • Saint Vincent's Hospital
      • Wodonga, Victoria, Australien, 3690
        • Border Medical Oncology, Murray Valley Private Hospital
  • Belgien
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint Luc
      • Haine-Saint-Paul, Belgien, 7100
        • Centre Hospitalier de Jolimont-Lobbes
    • Antwerpen
      • Edegem, Antwerpen, Belgien, 2650
        • Universitair Ziekenhuis Antwerpen
  • Brasilien
      • Rio de Janeiro, Brasilien, 20231
        • Instituto Nacional do Câncer
    • Distrito Federal
      • Brasilia, Distrito Federal, Brasilien, 70840
        • Hospital Universitario
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 60430-230
        • Santa Casa de Misericórdia de Belo Horizonte
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90610-000
        • Hospital Sao Lucas - PUCRS
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90020
        • Irmandade da Santa
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brasilien, 88034-000
        • CEPON-Centro de Pesquisas Oncológicas
    • Sao Paulo
      • Barretos, Sao Paulo, Brasilien, 14784-400
        • Hospital do Cancer de Barretos
      • Jau, Sao Paulo, Brasilien, 17210
        • Fundacao Hospital
      • Santo Andre, Sao Paulo, Brasilien, 09060-650
        • Faculdade de Medicina do ABC
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
  • Den Russiske Føderation
      • Ekaterinburg, Den Russiske Føderation, 620036
        • Sverdlovsk Regional Oncology Center
      • Irkutsk, Den Russiske Føderation, 664035
        • Regional Oncology Center
      • Krasnodar, Den Russiske Føderation, 350040
        • Clinical Oncology Center #1
      • Kursk, Den Russiske Føderation, 305035
        • Kursk Regional Oncology Center
      • Moscow, Den Russiske Føderation, 115478
        • Blokhin Cancer Research Center
      • Novosibirsk, Den Russiske Føderation, 630047
        • Novosibirsk, City Clinical Hospital #1
      • St. Petersburg, Den Russiske Føderation, 194291
        • Leningrad Regional Clinical Hospital
      • St. Petersburg, Den Russiske Føderation, 195067
        • Mechnikov St. Petersburg State Medical Academy
      • St. Petersburg, Den Russiske Føderation, 197785
        • St. Petersburg City Oncology Center
      • Tambov, Den Russiske Føderation, 392013
        • Tambov Regional Oncology Center
      • Tula, Den Russiske Føderation, 300053
        • Tula Regional Oncology Center
      • Yaroslavl, Den Russiske Føderation, 150040
        • Regional Clinical Oncology Hospital
    • Republic of Udmurtia
      • Izhevsk, Republic of Udmurtia, Den Russiske Føderation, 426067
        • Republic Clinical Oncology Center
  • Det Forenede Kongerige
    • England
      • London, England, Det Forenede Kongerige, W12 0HS
        • Hammersmith Hospital
      • Manchester, England, Det Forenede Kongerige, M20 4BX
        • Christie Hospital
    • Scotland
      • Glasgow, Scotland, Det Forenede Kongerige, G12 0YN
        • Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)
  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Arizona Center for Hematology Oncology
    • California
      • Corona, California, Forenede Stater, 92879
        • Wilshire Oncology Medical Group, Inc.
      • Los Angeles, California, Forenede Stater, 90033
        • White Memorial Medical Center
      • Los Angeles, California, Forenede Stater, 90036
        • Cancer Care Institute
      • Newport Beach, California, Forenede Stater, 92660
        • Newport Cancer Care Medical
      • Oakland, California, Forenede Stater, 94609
        • Hematology Oncology Associates
      • San Diego, California, Forenede Stater, 92123
        • Sharp Clinical Oncology Research
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06102
        • Hartford Hospital Clinical Research
      • Trumbull, Connecticut, Forenede Stater, 06611
        • Oncology Associates of Bridgeport
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Annapolis Oncology Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • The Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • New Mexico Cancer Care Alliance
    • New York
      • Lake Success, New York, Forenede Stater, 11042
        • Arena Oncology Associates, PC
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Bend Memorial Clinic
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Center Of The Carolinas
    • Texas
      • Corpus Christi, Texas, Forenede Stater, 78412
        • Cancer Specialists of South Texas, P.A.
      • Harlingen, Texas, Forenede Stater, 78550
        • Valley Cancer Associates
      • San Antonio, Texas, Forenede Stater, 78229
        • South Texas Oncology and Hematology, PA
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
  • Frankrig
      • Bayonne Cedex, Frankrig, 64109
        • Centre Hospitalier de la Cote Basque
      • Bordeaux, Frankrig, 33000
        • Hôpital Saint André, Service d'Oncologie Médicale
      • Limoges Cedex, Frankrig, 87039
        • Clinique Francois Chenieux
      • Montpellier, Frankrig, 34298
        • Centre Regional de Lutte contre le Cancer Val d'Aurelle
      • Montpellier Cedex 5, Frankrig, 34295
        • Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
      • Saint Herblain cedex, Frankrig, 44805
        • Centre René Gauducheau
      • Villejuif Cedex, Frankrig, 94805
        • Institut Gustave-Roussy - Centre de Lutte Contre le Cancer
  • Holland
    • Noord-Holland
      • Amsterdam, Noord-Holland, Holland, 1081 HV
        • Vrije Universiteit Medisch Centrum
  • Italien
      • Milano, Italien, 20132
        • Fondazione San Raffaele del Monte Tabor
      • Padova, Italien, 35128
        • Instituto Oncologico Veneto, Oncologia Medica 1
      • Torrette di Ancona, Italien, 60020
        • Ospedali Riuniti di Ancona
      • Verona, Italien, 37134
        • Centro Ricerche Cliniche di Verona
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • Norge
      • Kristiansand, Norge, 4604
        • Sørlandet Sykehus HF
      • Oslo, Norge, 0407
        • Oslo universitetssykehus, Ullevål
  • Sverige
      • Jonkoping, Sverige, 551 85
        • Länssjukhuset Ryhov
      • Linköping, Sverige, 581 85
        • Linköping University Hospital
      • Växjö, Sverige, 351 85
        • Växjö Centrallasarettet
  • Tyskland
      • Berlin, Tyskland, 13353
        • Charité Universitätsmedizin Berlin
      • Dresden, Tyskland, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Magdeburg, Tyskland, 39120
        • Klinik der Otto-Von-Guericke-Universität Magdeburg
      • Ulm, Tyskland, 89081
        • Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I
    • Bayern
      • München, Bayern, Tyskland, 81377
        • Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Tyskland, 17475
        • Klinikum der Ernst-Moritz-Arndt-Universität
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Tyskland, 44892
        • Knappschaftskrankenhaus Bochum-Langendreer
    • Thueringen
      • Jena, Thueringen, Tyskland, 07740
        • Universitätsklinikum Jena
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology
      • Donetsk, Ukraine, 83092
        • Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6
      • Kharkiv, Ukraine, 61070
        • "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department
      • Kiev, Ukraine, 03022
        • National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum
      • Lviv, Ukraine, 79031
        • State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department
      • Mykolayiv, Ukraine, 54044
        • Mykolayiv Regional Oncology Center, Surgery Department #1
      • Uzhorod, Ukraine, 88014
        • Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department
      • Zaporizhya, Ukraine, 69032
        • Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1

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:

  • Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
  • Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.
  • Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
  • Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
  • CT scan ≤30 days prior to randomization
  • Performance Status (ECOG) 0 or 1.
  • Estimated life expectancy ≥ 12 weeks.
  • Age ≥ 18 years.
  • Adequate hematological and biological function.
  • Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.

Exclusion Criteria:

  • Prior palliative chemotherapy for pancreatic cancer.
  • Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
  • Symptomatic brain metastases.
  • Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
  • Concomitant treatment with prohibited medications.
  • History of allergy to gemcitabine or eggs.
  • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
  • Any disorder that would hamper protocol compliance.
  • Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
  • Females who are pregnant or breastfeeding.
  • Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
  • Any other reason the investigator considers the patient should not participate in the study.

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: gemcitabin
Medicin: Gemcitabine
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
Eksperimentel: CO-1.01
Medicin: CO-1.01
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Tidsramme: Monthly follow up after treatment discontinuation until death, up to 1.5 years.
Monthly follow up after treatment discontinuation until death, up to 1.5 years.

Sekundære resultatmål

Resultatmål
Tidsramme
Overall Survival in All Patients and Patients With hENT1 Expression
Tidsramme: Monthly follow up after treatment discontinuation until death, up to 1.5 years
Monthly follow up after treatment discontinuation until death, up to 1.5 years
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Tidsramme: Every 8 weeks
Every 8 weeks
Cancer Antigen (CA)19-9 Response Rates
Tidsramme: Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Drug Tolerability and Toxicity
Tidsramme: Every week, up to 1.5 years
Every week, up to 1.5 years
Change From Baseline in Pain Severity
Tidsramme: Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Change From Baseline in Health Status
Tidsramme: Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Tidsramme: 30 days after first dose
30 days after first dose

Samarbejdspartnere og efterforskere

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

Sponsor

Clovis Oncology, Inc.

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. maj 2010

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

12. maj 2010

Først indsendt, der opfyldte QC-kriterier

14. maj 2010

Først opslået (Skøn)

17. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CO-101-001

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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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United States

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner