A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 10, 2023

Primary Completion Date

January 31, 2025

Study Completion Date

March 31, 2025

Conditions
Colorectal CancerMetastatic Colon Cancer
Interventions
DRUG

Ompenaclid

Ompenaclid (RGX-202-01)

DRUG

Placebo

Placebo

DRUG

Bevacizumab

Bevacizumab

DRUG

FOLFIRI regimen

FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle)

Trial Locations (28)

1090

UZ Brussel, Brussels

1200

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

2650

Antwerp University Hospital, Antwerp

2820

Imelda Ziekenhuis, Bonheiden

3000

UZ Leuven, Leuven

4000

CHU de Liège University hospital in Liège, Liège

6000

Grand Hoptial De Charleroi, Charleroi

13009

Institut Paoli-Calmettes, Marseille

14004

Hospital Universitario Reina Sofía, Córdoba

21000

Centre Georges-François Leclerc, Dijon

22190

Hopital Prive des Cotes d'Armor, Plérin

25000

CHU Hôpital Jean Minjoz, Besançon

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28220

Hospital Puerta de Hierro Majadahonda, Majadahonda

28222

Hospital Puerta de Hierro Majadahonda, Madrid

39008

Hospital Universitario Marqués de Valdecilla, Santander

41014

Hospital Universitario Virgen de Valme, Seville

44093

CHU Nantes -hopital hotel Dieu, Nantes

44805

Institut de Cancerologie de l'Ouest, Saint-Herblain

46010

Hospital Clinico De Valencia, Valencia

Hospital Clinico Universitario De Valencia, Valencia

75074

Groupe Hospitalier Paris Saint Joseph - Oncologie, Paris

94805

Institut Gustave Roussy, Villejuif

Unknown

Institut Jules Bordet, Anderlecht

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall D Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Inspirna, Inc.

INDUSTRY

NCT05983367 - A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter