NCT05694936View on ClinicalTrials.gov

Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

January 23, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

June 30, 2027

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Sodium Valproate

Sodium valproate oral continuously in a twice daily dose (Initial dose of 600mg/d up-titrated to target daily dose of 20 mg/kg/d at Cycle 1 Day 13, then dose adjusted to maintain serum VPA levels within the target range of 50-100 μg/mL); Refer to arm description.

DRUG

Panitumumab

Panitumumab 6 mg/kg IV every 2 weeks or cetuximab 500 mg/m2 IV every 2 weeks; Refer to arm description.

DRUG

Cetuximab

Panitumumab 6 mg/kg IV every 2 weeks or cetuximab 500 mg/m2 IV every 2 weeks; Refer to arm description.

Trial Locations (11)

2065

RECRUITING

Royal North Shore Hospital, Saint Leonards

2145

RECRUITING

Western Sydney Local Health District, Westmead

3000

RECRUITING

Peter MacCallum Cancer Institute, Melbourne

3084

RECRUITING

Austin Health, Melbourne

3128

RECRUITING

Eastern Health, Box Hill

3199

RECRUITING

Peninsula Health, Frankston

3280

RECRUITING

South West Healthcare, Warrnambool

3350

RECRUITING

Grampians Health, Ballarat Central

4029

RECRUITING

Royal Brisbane and Women's Hospital, Herston

5000

RECRUITING

Queen Elizabeth Hospital, Adelaide

5042

RECRUITING

Southern Adelaide Local Health Network Incorporated, Bedford Park

All Listed Sponsors
collaborator

Olivia Newton-John Cancer Research Institute

OTHER

lead

Australasian Gastro-Intestinal Trials Group

NETWORK