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

12 marzo 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

367

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: gemcitabina
Droga: Gemcitabine
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
Sperimentale: CO-1.01
Droga: CO-1.01
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Overall Survival in All Patients and Patients With hENT1 Expression
Lasso di tempo: 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
Lasso di tempo: Every 8 weeks
Every 8 weeks
Cancer Antigen (CA)19-9 Response Rates
Lasso di tempo: Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Drug Tolerability and Toxicity
Lasso di tempo: Every week, up to 1.5 years
Every week, up to 1.5 years
Change From Baseline in Pain Severity
Lasso di tempo: Every 4 weeks, up to 1.5 years
Every 4 weeks, up to 1.5 years
Change From Baseline in Health Status
Lasso di tempo: 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
Lasso di tempo: 30 days after first dose
30 days after first dose

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Clovis Oncology, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2010

Completamento primario (Effettivo)

1 novembre 2012

Completamento dello studio (Effettivo)

1 giugno 2013

Date di iscrizione allo studio

Primo inviato

12 maggio 2010

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2010

Primo Inserito (Stima)

17 maggio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 aprile 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 marzo 2014

Ultimo verificato

1 marzo 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CO-101-001

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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