Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

VADER : A Phase II Randomised Controlled 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 (CRC)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colorectum

Trial Overview Read MoreRead more

This phase II study is trying to determine whether combining valproic acid (sodium valproate) to targeted therapy (panitumumab or cetuximab) is more effective than compared targeted therapy alone in people with RAS wild type metastatic bowel cancer.
 

This trial is treating patients with metastatic bowel cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase II Randomised Controlled 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 (CRC)

Cooperative Group

Australasian Gastro-Intestinal Trials Group (AGITG)

Other Non-Commercial Sponsor

Olivia Newton-John Cancer Research Institute

Summary

Eligible participants will be randomly allocated to either the Experimental or Active Comparator Arm. In the Experimental Arm, participants will receive either panitumumab (6mg/kg intravenously every 2 weeks) or cetuximab (500mg/m2 intravenously every 2 weeks), plus sodium valproate, orally, in a twice daily dose (target daily dose of 20mg/kg/d at Cycle 1 Day 13, then dose adjusted to maintain serum VPA levels within the target range of 50-100 μg/mL). In the Active Comparator Arm, participants will receive either panitumumab (6mg/kg intravenously every 2 weeks) or cetuximab 500mg/m2 intravenously every 2 weeks).

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Grampians Health
Ballarat
Ms Carmel Goss
CarmelG@bhs.org.au
03 5320 4735

Peninsula Health
Frankston
Oncology Research Enquiries
OncologyResearch@phcn.vic.gov.au

Peninsula Health
Capel Sound (Rosebud West)
Oncology Research Enquiries
OncologyResearch@phcn.vic.gov.au

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Monc B Co-Team Leads
PCCTU.MoncB@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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