RecruitingPhase 2NCT05694936

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

A Phase II Trial to Determine the Efficacy of Combining the HDAC Inhibitor Sodium Valproate With EGFR Monoclonal Antibody (Panitumumab or Cetuximab) Maintenance in the First-line Treatment of Patients With RAS Wild Type Metastatic Colorectal Cancer (VADER Study).


Sponsor

Australasian Gastro-Intestinal Trials Group

Enrollment

90 participants

Start Date

Jan 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to determine the efficacy of combining the histone deacetylase (HDAC) inhibitor sodium valproate (VPA) with anti-EGFR monoclonal antibody (panitumumab or cetuximab) maintenance in the first-line treatment of patients with RAS wild type metastatic CRC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding sodium valproate — a drug commonly used for epilepsy — to standard targeted antibody therapy (cetuximab or panitumumab) improves outcomes for people with metastatic colorectal cancer that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with colorectal cancer that has spread and cannot be cured by surgery - Your cancer has a specific genetic profile called RAS wild type (meaning it lacks certain mutations) - You have completed about 4 months of first-line chemotherapy and your cancer responded or stabilized - You are well enough to carry out daily activities (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has RAS mutations - You are already on valproate or have a history of valproate-related complications - You have severe liver problems - You are pregnant or breastfeeding - You have uncontrolled other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium 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.

DRUGPanitumumab

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

DRUGCetuximab

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


Locations(11)

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Western Sydney Local Health District

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Queen Elizabeth Hospital

Adelaide, South Australia, Australia

Southern Adelaide Local Health Network Incorporated

Bedford Park, South Australia, Australia

Grampians Health

Ballarat Central, Victoria, Australia

Eastern Health

Box Hill, Victoria, Australia

Peninsula Health

Frankston, Victoria, Australia

Peter MacCallum Cancer Institute

Melbourne, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

South West Healthcare

Warrnambool, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT05694936


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