Trial · NCT05694936
Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer
NCT05694936, Phase 2, Active not recruiting, Australasian Gastro-Intestinal Trials Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer. Trials, record NCT05694936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05694936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer
- NCT number
- NCT05694936
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Sodium Valproate, Panitumumab, Cetuximab
- First posted
- 2023-01-23
- Last updated
- 2026-05-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival | 12 Months from randomisation | Progression free survival (PFS) will be defined as the interval from date of registration or randomisation to the date of first evidence of disease progression (measured by RECIST v1.1 criteria) or death whichever occurs first, in each treatment arm. |
| Secondary | Overall Survival | 12 Months from randomisation | Overall survival (OS) will be defined as the interval from date of registration or randomisation to date of death from any cause. |
| Secondary | Objective response rates (ORRs) | 12 Months from randomisation | ORRs will be calculated as the proportion of participants in each arm who are assessed as having a complete or partial response measured by RECIST v1.1. |
| Secondary | Quantification of the incidence of treatment-emergent adverse events according to CTCAE V5.0 | 12 Months from randomisation | Safety of each treatment arm will be assessed by evaluating the number and severity (grade) of adverse events reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). |
| Other | Health-related quality of life (EORTC QLQ-C30) | 12 Months from randomisation | Health-Related Quality of Life (HRQoL) will be determined by the global and subscale scores outlined in the EORTC user manual and scoring guidelines. Scores are from 0-100, with higher scores indicating better quality of life. |
| Other | Health-related quality of life (EQ-5D-5L) | 12 Months from radomisation | The EQ-5D-5L will be used to derive utility scores suitable for quality adjusted survival analyses. The scale has five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which are scored at one of five levels ranging from no problems to extreme problems. |
| Other | Quantification of histone acetylation levels in peripheral blood mononuclear cells (PBMCs) | 12 Months from radomisation | Exploratory analysis detecting changes in levels of histone acetylation in PBMCs during treatment |
| Other | Quantification of total circulating tumour DNA (ctDNA) | 12 Months from radomisation | Exploratory analysis detecting the levels of ctDNA during treatment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05694936
GET https://conductscience.org/api/trials/v1/NCT05694936/registered