Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2030

Conditions
Pancreatic Adenocarcinoma
Interventions
DRUG

Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)

A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX) in combination with sotorasib 960 mg daily (QD). The treatment with gem/nab-P and mFOLFIRINOX should be managed as per clinical practice.

Trial Locations (25)

Unknown

Sainte Catherine - Institut Avignon Provence, Avignon

Chu Besançon - Hôpital Jean Minjoz, Besançon

Chu Brest - Hôpital Morvan, Brest

Chu de Lille - Claude Huriez, Lille

Hôpital Léon Berard, Lyon

Chu Bordeaux - Hôpital Haut Lévêque, Pessac

Chu Poitiers, Poitiers

Chu Reims - Hôpital Robert Debré, Reims

Chu Toulouse, Toulouse

Hôpital Paul-Brousse, Villejuif

Hospital Universitario Miguel Servet, Zaragoza

Hospital Universitari Vall D'Hebron, Barcelona

Institut Català D'Oncologia L'Hospitalet (Ico), Barcelona

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Reina Sofía, Córdoba

Hospital Universitario Donostia-Donostia Unibertsitate Ospitalea, Donostia / San Sebastian

Hospital Clínico San Carlos, Madrid

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario 12 de Octubre, Madrid

Complejo Hospitalario Regional de Málaga, Málaga

Complejo Hospitalario de Navarra, Pamplona

Complexo Hospitalario Universitario de Ourense, Ourense

Hospital Universitario Central de Asturias, Oviedo

Hospital Universitario de Salamanca, Salamanca

Hospital General Universitario de Valencia, Valencia

All Listed Sponsors
collaborator

Apices Soluciones S.L.

INDUSTRY

collaborator

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER