ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

March 12, 2025

Primary Completion Date

December 20, 2026

Study Completion Date

June 20, 2027

Conditions
Colorectal Cancer Metastatic
Interventions
DRUG

irinotecan

Administered at the dosage of 180 mg/m2 over 60 minutes

DRUG

panitumumab

Administered as 60 minutes, or 90 minutes for doses over 1000 mg, intravenous infusion at the dosage of 6 mg/kg

DRUG

Valproic Acid (VPA)

"VPA will be administered in each patient with a titration strategy to improve the compliance for the treatment, looking for a target serum level between 50 and 100 μg/mL that represents the recommended values for the treatment of epilepsy and also a useful concentration to produce the desired synergistic effect with chemotherapy based on preclinical studies.~Administrated at the dosage of 500 mg/three times a day (after 7 days of gradual dose escalation)."

Trial Locations (5)

80131

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli

Unknown

RECRUITING

AORN Sant'Anna e San Sebastiano, Caserta

NOT_YET_RECRUITING

Università degli studi della Campania Luigi Vanvitelli, Napoli

ACTIVE_NOT_RECRUITING

AORN San Giuseppe Moscati Avellino, Avellino

NOT_YET_RECRUITING

Pia Fondazione Di Culto E Religione Card G Panico, Tricase

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER