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Combination With Gemcitabine in Advanced Pancreatic Cancer (BAGPAC)

6. april 2021 opdateret af: Bayer

A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer

Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.

Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.

Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.

Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles - Brussel, Belgien, 1070
      • Bruxelles - Brussel, Belgien, 1090
      • Edegem, Belgien, 2650
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
      • London, Det Forenede Kongerige, SE1 9RT
      • London, Det Forenede Kongerige, WC1E 6BT
  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
    • Massachusetts
      • Pittsfield, Massachusetts, Forenede Stater, 01201
  • Frankrig
      • CLERMONT-FERRAND Cedex 1, Frankrig, 63003
  • Italien
    • Lombardia
      • Brescia, Lombardia, Italien, 25124
    • Marche
      • Ancona, Marche, Italien, 60126
  • Norge
      • Oslo, Norge
      • Oslo, Norge, 0310
  • Polen
      • Bialystok, Polen, 15-027
      • Gdansk, Polen, 80-952
      • Warszawa, Polen, 02-781
  • Tjekkiet
      • Brno, Tjekkiet, 602 00
      • Olomouc, Tjekkiet, 775 20
  • Tyskland
      • Berlin, Tyskland, 13353
    • Baden-Württemberg
      • Heilbronn, Baden-Württemberg, Tyskland, 74078
    • Bayern
      • München, Bayern, Tyskland, 81377
    • Hessen
      • Marburg, Hessen, Tyskland, 35033
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Tyskland, 44892

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 til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female patients ≥18 years of age
  • Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
  • Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
  • Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
  • Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
  • Patient has cardiac function, within normal range, as measured by an echocardiogram

Exclusion Criteria:

  • Known history of, or symptomatic metastatic brain or meningeal tumors
  • History of cardiac disease
  • Active clinically serious infections
  • Clinically significant (ie. symptomatic) peripheral vascular disease
  • Pregnant or lactating women; women of childbearing potential not employing adequate contraception
  • Use of strong inhibitors or inducers of CYP3A4
  • Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy
  • Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment
  • Thrombotic or embolic events such within 6 months prior to start of study treatment

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
Medicin: BAY86-9766+Gemcitabine
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
Tidsramme: From randomization up to the first 8 weeks of therapy
From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Tumor Response: Investigator Assessment: Phase I
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response (DOR): Phase I
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response: Phase II
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase I
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase II
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase I
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase II
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase I
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase II
Tidsramme: From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Bayer

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.

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 (Faktiske)

1. januar 2011

Primær færdiggørelse (Faktiske)

11. februar 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

8. november 2010

Først indsendt, der opfyldte QC-kriterier

1. december 2010

Først opslået (Skøn)

2. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14905
  • 2010-019588-12 (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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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner