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A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

13. maj 2016 opdateret af: Hoffmann-La Roche

A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

207

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Kogarah, New South Wales, Australien, 2217
      • St. Leonards, New South Wales, Australien, 2065
      • Sydney, New South Wales, Australien, 2076
    • Victoria
      • Box Hill, Victoria, Australien, 3128
  • Brasilien
    • BA
      • Salvador, Bahia, BA, Brasilien, 40170-380
    • MG
      • Belo Horizonte, MG, Brasilien, 30110-0090
    • PR
      • Curitiba, PR, Brasilien, 81520-060
    • RS
      • Ijui, RS, Brasilien, 98700-000
      • Porto Alegre, RS, Brasilien, 90430-090
      • Porto Alegre, RS, Brasilien, 91350-200
      • Porto Alegre, RS, Brasilien, 90020-090
    • SP
      • Jau, SP, Brasilien, 17210-080
      • Sao Paulo, SP, Brasilien, 01246-000
      • Sao Paulo, SP, Brasilien, 05652-000
  • Bulgarien
      • Gabrovo, Bulgarien, 5300
      • Pleven, Bulgarien, 5800
      • Plovdiv, Bulgarien, 4004
      • Sofia, Bulgarien, 1756
      • Sofia, Bulgarien, 1233
      • Sofia, Bulgarien, 1431
      • Vratsa, Bulgarien, 3000
      • Vratza, Bulgarien, 3000
  • Den Russiske Føderation
      • Irkutsk, Den Russiske Føderation, 664035
      • Kazan, Den Russiske Føderation, 420111
      • Krasnodar, Den Russiske Føderation, 350040
      • Moscow, Den Russiske Føderation, 115478
      • St Petersburg, Den Russiske Føderation, 195067
      • St Petersburg, Den Russiske Føderation, 198255
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE1 9RT
      • London, Det Forenede Kongerige, N18 1QX
      • London, Det Forenede Kongerige, SW3 6JJ
      • London, Det Forenede Kongerige, EC1A 7BE
      • Sutton, Det Forenede Kongerige, SM2 5PT
  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong, 852
  • Indien
      • Bangalore, Indien, 560029
      • Chennai, Indien, 600035
      • Jaipur, Indien, 302004
      • Kochi, Indien, 682304
      • Kolkata, Indien, 700053
      • Ludhiana, Indien, 141 001
      • Mumbai, Indien, 400012
      • New Delhi, Indien, 110076
      • Pune, Indien, 411 001
      • Vellore, Indien, 632004
  • Italien
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italien, 33100
  • Kroatien
      • Zagreb, Kroatien, 10000
  • Letland
      • Riga, Letland, LV-1002
  • Litauen
      • Kaunas, Litauen, 50009
      • Vilnius, Litauen, 08660
      • Vilnius, Litauen, 08661
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
      • Penang, Malaysia, 11200
  • Mexico
      • Monterrey, Mexico, 64020
  • Peru
      • Arequipa, Peru, 04001
      • Chiclayo, Peru, CIX
      • San Isidro, Peru, L27 Lima
  • Rumænien
      • Bucharest, Rumænien
      • Cluj Napoca, Rumænien, 400015
      • Craiova (Dolj county), Rumænien, 200535
  • Singapore
      • Singapore, Singapore, 169610
  • Slovenien
      • Ljubljana, Slovenien, 1000
  • Tyskland
      • Bochum, Tyskland, 44791
      • Dresden, Tyskland, 01307
      • Esslingen, Tyskland, 73730
      • Greifswald, Tyskland, 17489
      • Hamburg, Tyskland, 20148
      • Köln, Tyskland, 50937
      • Saarbruecken, Tyskland, 66113
      • Ulm, Tyskland, 89081
  • Ukraine
      • Kiev, Ukraine, 36022

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:

  • adult patients, >=18 years of age;
  • histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
  • measurable disease according to RECIST;
  • failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
  • ECOG performance status of 0-2.

Exclusion Criteria:

  • local or locally advanced-resectable pancreatic cancer;
  • any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
  • major surgery within 2 weeks prior to randomization.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Erlotinib
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Medicin: Erlotinib
Participants received erlotinib 150 mg tablet orally once daily.
Andre navne:
  • Tarceva
Placebo komparator: Placebo
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Medicin: Placebo
Participants received placebo matching to erlotinib 150 mg tablet orally once daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival
Tidsramme: From the time of randomization until progression of disease or death (up to 30 months)
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.
From the time of randomization until progression of disease or death (up to 30 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Best Overall Response Rate
Tidsramme: From the time of randomization until progression of disease or death (up to 30 months)
Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
From the time of randomization until progression of disease or death (up to 30 months)
Percentage of Participants With Disease Control Rate (DCR)
Tidsramme: Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Overall Survival
Tidsramme: From the time of randomization until or death (up to 30 months)
Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.
From the time of randomization until or death (up to 30 months)
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to 28 days after discontinuation of study drug (up to 30 months)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Up to 28 days after discontinuation of study drug (up to 30 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

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

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. juni 2008

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

30. april 2008

Først indsendt, der opfyldte QC-kriterier

7. maj 2008

Først opslået (Skøn)

8. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BO21129
  • 2007-003738-40 (EudraCT nummer)

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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