Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

December 7, 2020

Primary Completion Date

June 15, 2023

Study Completion Date

December 31, 2025

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

Arm A - Olaparib

"300 mg orally twice daily, for a total daily dose of 600mg~Study treatment can be dose-reduced to :~First step : 250 mg twice daily , for a total daily dose of 500 mg Second step: 200 mg twice daily taken twice daily, for a total daily dose of 400 mg No further dose reduction is allowed, and study treatment should be discontinued."

DRUG

ARM B - durvalumab plus selumetinib

"Durvalumab administered IV at a flat dose of 1500 mg on day 1 of every 28-day cycle, Selumetinib Starting Dose : 75 mg twice daily~Study treatment can be dose-reduced to :~Dose Level -1 : 75 mg once daily Dose Level -2 : 50 mg twice daily Dose Level -3 : 50 mg once daily"

DRUG

ARM C FOLFIRI

FOLFIRI every two weeks Irinotecan 180 mg/m2 Intravenous (IV) on day 1 Folinic acid 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 and 2, and 46h IV infusion of 5-FU 2400 mg/m2

Trial Locations (29)

Unknown

Institut Sainte Catherine, Avignon

CHRU Jean Minjoz, Besançon

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

Centre François Baclesse, Caen

Hôpital Beaujon, Clichy

GHPSO Site de Creil, Creil

Centre Georges François Leclerc, Dijon

CHU Dijon, Dijon

CHU Grenoble Alpes Hôpital Michallon, Grenoble

Hôpital Franco-Britannique, Levallois-Perret

CHRU Lille, Lille

centre Léon Bérard, Lyon

Hôpital Privé Jean Mermoz, Lyon

Hôpital Saint Joseph Saint Luc, Lyon

CHU La Timone, Marseille

Hôpital Européen, Marseille

Institut Paoli Calmette, Marseille

Hôpital Nord Franche Comté, Montbéliard

GH Diaconesses Croix Saint Simon, Paris

Hôpital Européen Georges Pompidou, Paris

Hôpital Pitié Salpêtrière, Paris

Hôpital Saint Antoine, Paris

Institut Mutualiste Montsouris, Paris

CHU Poitiers, Poitiers

CHU Robert Debré, Reims

ICO Site de Saint Herblain, Saint-Herblain

Centre Paul Strauss, Strasbourg

CHU Toulouse IUCT Rangueil, Toulouse

Hôpital Trousseau, Tours

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER