last updated at 14.11.2019

POLO-D081FC00001

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy (POLO)

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS
2014-001589-85 NCT02184195

Diagnose

  • Pankreaskarzinom (Bauchspeicheldrüsenkrebs)

Studienziel / Fragestellung

Primäres Prüfziel
    • Progression free survival (PFS) by central review of modified RECIST 1.1
    • Efficacy by assessment of PFS (time from randomisation to objective disease progression according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) or death) of olaparib maintenance monotherapy compared to placebo
    • using blinded independent central review (BICR) of radiological scans.
Sekundäre Prüfziele
    • Overall survival (OS) [ Time Frame: Up to 4 years
    • Time from randomisation to second progression or death (PFS2)
    • Time from randomisation to first subsequent therapy or death

Patientenmerkmale

Alter

18-99

Ausschlusskriterien

     

  • gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc.)
  • Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation.
  • Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle

    1 Day 1 is not permitted.

  • Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
  • Any previous treatment with a PARP inhibitor, including Olaparib
  •  

Einschlusskriterien

     

  • Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
  • Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study.
  • Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
  • Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion.
  • Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.
  •  

Studiendesign

  • Doppelblind
  • Multizentrisch
  • Phase III
  • Placebo-kontrolliert
  • Randomisiert

Intervention

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • AstraZeneca GmbH

Prüfzentrum 1

 

  • Medizinische Klinik I (UKBonn)

Studienbüro

  • Studienzentrum Onkologische Gastroenterologie

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. med. Christian Strassburg

Stellvertretender Prüfer

  • PD Dr. med. Maria Gonzalez-Carmona

Studienkontakt im Prüfzentrum

  • PD Dr. med. Maria Gonzalez-Carmona
  • Prof. Dr. med. Christian Strassburg

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