Trial · NCT05323656
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Percentage Change in Tumour Size | Baseline to at least 15 weeks and up to 51 weeks | Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1. |
| Secondary | Progression Free Survival (PFS) | Baseline up to approximately 21 months | Defined as time from randomisation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. |
| Secondary | Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue | Baseline up to approximately 9 weeks | Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue | Baseline up to approximately 9 weeks | Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue | Baseline up to approximately 9 weeks | Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Overall Response Rate (ORR) | Baseline up to approximately 12 months | Proportion of the patients who have a complete response (CR) or partial response (PR) per RECIST v1.1 will be used to access ORR. |
| Secondary | Duration of Response (DoR) | Baseline up to approximately 12 months | The minimum time when CR or PR is first observed to the time of progression of disease (PD) or death will be used to access DoR. |
| Secondary | Disease Control Rate (DCR) | Baseline up to approximately 12 months | Proportion of the patients in whom the best overall response is determined as CR, PR, or stable disease (SD) per RECIST v1.1 will be used to access DCR. |
| Secondary | Overall Survival (OS) | Baseline up to 12 months | Defined as the time from randomisation to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up. |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline up to approximately 21 months | Any clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests (including biochemistry, hematology, urinalysis, and thyroid function), or 12- lead electrocardiogram (ECG) results will be recorded as Adverse Events (AEs). |
| Secondary | Number of Participants With Adverse Events of Special Interest (AESI) | Baseline up to approximately 21 months | AESI include Anaemia and Hypothyroidism. |
| Secondary | Levels of Programmed Death-ligand 1 (PD-L1) Expression in Tumour Tissue | Baseline up to approximately 9 weeks | Combined Positive Score (CPS) is a scoring method that predicts response to pembrolizumab in patients with cancer defined as the number of PD-L1-staining cells (tumor cells, lymphocytes, and macrophages) relative to the total number of viable tumor cells. A higher CPS score indicates an increased likelihood to respond to pembrolizumab treatment. It was hypothesized based on the mode of action of setanaxib that there would be an increased immunological response and therefore an increase in PD-L1 in tumor tissue. Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups. |
| Secondary | Change From Baseline in CAFs Cell Type Abundance Based on Gene Expression Profiles | Baseline up to approximately 9 weeks | Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of myofibroblastic CAF were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data. CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles. |
| Secondary | Change From Baseline in CD8+ TILs Cell Type Abundance Based on Gene Expression Profiles | Baseline up to approximately 9 weeks | Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of tumor-infiltrating lymphocytes (TILs) were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data. CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles. |
| Secondary | Change From Baseline in Regulatory T-cell Abundance Based on Gene Expression Profiles | Baseline up to approximately 9 weeks | Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of regulatory T-cells were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data. CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles. |
| Secondary | Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC[0-24]-ss) of Setanaxib | Baseline, Week 3, week 9, week 24, week 51 | |
| Secondary | Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC24-ss) of GKT138184 | Baseline, Week 3, week 9, week 24, week 51 | |
| Secondary | Minimum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib | Baseline, Week 3, week 9, week 24, week 51 | |
| Secondary | Minimum Plasma Concentration at Steady State (Cmin-ss) of GKT138184 | Baseline, Week 3, week 9, week 24, week 51 | |
| Secondary | Maximum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib | Baseline, Week 3, week 9, week 24, week 51 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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