Trial · NCT05950464
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicities (DLTs) (Part I) | Within the first cycle of study treatment (up to 28 days) | DLT is defined as any adverse events considered possibly, probably or definitely related to study drug combination as evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. A Bayesian Optimal Interval (BOIN) design will be used to determine the MTD (Yuan et al. 2016). Will be summarized by dose level. |
| Primary | DLTs (Part II) | Within the first 2 cycles of study treatment (up to 56 days) | DLT is defined as any adverse events considered possibly, probably or definitely related to study drug combination as evaluated by NCI CTCAE v5.0. Within the ARID1A cohorts, the number of patients with DLTs will be summarized, and adverse events tabulated using the highest observed grade for each system organ class or preferred term, using CTCAE v5.0 criteria by cohort. |
| Primary | Measurements for gammaH2AX (PART II) | Baseline and cycle 1, day 8 (C1D8) | GammaH2AX will be assessed by immunohistochemistry (IHC) from tumor samples. Will be summarized using descriptive statistics (e.g., mean, standard deviation, median) by cohort and collection time point. One-sided Wilcoxon signed rank tests will be used for testing whether there is a change in gammaH2AX expression in the pre-treatment vs on-treatment tumor in the patients who have been treated at the recommended phase 2 dose (RP2D) and have evaluable bio-specimen by cohort, respectively. |
| Primary | Incidence of adverse events (Part I and II) | Up to 5 years | The frequency and severity of adverse events will be assessed by CTCAE v5. |
| Secondary | Measurements for c-myc (Part II) | Baseline and C1D8 | Will be assessed by Digital Spatial Profiling (DSP) using tumor samples. Will be summarized using descriptive statistics (e.g., mean, standard deviation, median) by cohort, biospecimen type, and collection time point. One-sided Wilcoxon signed rank tests will be applied to examine whether there is a change in c-myc expression in the pre-treatment vs on-treatment tumor in the patients who have been treated at the RP2D and have evaluable bio-specimen by cohort, respectively. |
| Secondary | Measurements for gammaH2AX (Part II) | Baseline and C1D8 | Will be assessed by DSP using tumor samples. Analyses will be performed in similar approach to the primary endpoint gammaH2AX expression by IHC. |
| Secondary | Measurements for ARID1A protein and pathogenic alteration status (Part II) | Baseline, C1D8, and at progression | Summary statistics (e.g., mean and standard deviation, median) for ARID1A protein by IHC and DSP in pre-treatment tumor will be provided for the 12-point score (measure of ARID1A positive staining cells by IHC) by cohort and mutation status (Khalique et al, 2018). ARID1A pathogenic alteration means there is loss of ARID1A protein as assessed by IHC and DSP. ARID1A wildtype means there is no mutation and ARID1A protein is present. The relationship between ARID1A protein and ARID1A pathogenic alteration status will be investigated by Wilcoxon rank-sum test. |
| Secondary | Objective response rate (Part II) | At 6 months | Objective response rate (ORR) is defined as the binomial proportion of evaluable patients with best overall response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of complete or partial response (CR or PR). |
| Secondary | Progression-free survival (Part II) | From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months | Progression-free survival at six months (PFS) is defined as the binomial proportion of evaluable patients who survive without documentation of disease progression (RECIST 1.1) at least 6 months after starting study entry. |
| Other | Measurements of blood pharmacokinetics (PK) for ZEN003694 and ZEN003791 (Part I) | C1D1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, & 8 hours [hrs]); C1D8 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, & 8 hrs) | PK endpoints (area under the curve \[AUC\], maximum concentration \[Cmax\] and metabolic ratio of ZEN003694 and active metabolite ZEN003791, and M1774) will be summarized using descriptive statistics by dose level. |
| Other | Measurements for ARID1A protein (Part I) | Baseline | ARID1A status and molecular profiles will be tabulated retrospectively. |
| Other | Objective response rate (Part I) | At 6 months | |
| Other | Progression-free survival (Part I) | From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months | |
| Other | Measurements of biomarker molecular profile (Part I) | Up to 5 years | Will assess profiles by Next Generation Sequencing from somatic tumor, correlate other molecular alterations (e.g., PIK3CA, C-Myc) with response by RECIST 1.1 and CA-125 by Gynecological Cancer Intergroup (GCIG). |
| Other | Measurements of blood PK for ZEN003694 and ZEN003791 when taken alone or with M1774 (Part II) | C1D1 (Pre-dose & 2 hrs); C1D8 (2 hrs) | Will be summarized using descriptive statistics by dose level and non-linear model techniques. |
| Other | Correlation of objective response rate, CA-125 response, and overall survival (OS) with ARID1A pathogenic alteration status (Part II) | Up to 5 years | Objective tumor response (complete or partial response) by RECIST 1.1 and GCIG CA-125 will be tabulated by cohort, respectively, and the proportion of patients with response will be estimated and compared between the two cohorts by Fisher's exact test. |
| Other | Correlation of measurements for PK and pharmacodynamics (e.g., gH2AX and MYC) (Part II) | Up to 5 years | Descriptive statistics or mixed modeling approaches may be used to explore the corresponding associations of pharmacodynamic biomarkers with PK plasma concentration for ZEN003694. |
| Other | Measurements for ARID1A genetic status, ARID1A protein level, gammaH2AX, c-myc, total ATM, HEXIM1 | Up to 5 years | Will assess ARID1A protein level (IHC and DSP), gammaH2AX (IHC and DSP), c-myc (DSP), total ATM (DSP), HEXIM1 by ribonucleic acid sequencing (RNASeq) in tumor biopsies, and correlation with objective response rate, and progression-free survival. Will be explored by Spearman's correlation coefficient, respectively. |
| Other | Correlation of ARID1A gene alteration in circulating free tumor deoxyribonucleic acid (ctDNA) with tumor ARID1A genetic status and protein expression | Up to 5 years | Summary statistics for ARID1A genetic status from pre-treatment blood specimen will be provided, and the associations of it with tumor ARID1A genetic status and protein expression from pre-treatment biopsies, and objective tumor response will be explored by appropriate non-parametric methods, e.g., Spearman's correlation coefficient methods for ordinal-type data. |
| Other | Measurements for ARID1A expression | At pre-treatment | Will be assessed by NGS (gene alteration) and IHC from archival tumor and compare to most recent pre-treatment biopsy. The ARID1A genetic status and protein in archival tumor and most recent pre-treatment biopsy will be summarized by time, and the corresponding changes will be explored using Wilcoxon's signed rank tests or repeated measures methods. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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