Trial · NCT04195399
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to 2 years from study entry | The Kaplan-Meier method will be used to estimate the 2-year PFS defined as the time from study entry until disease progression or death from any cause. |
| Primary | Percentage of patients experiencing grade 3+ adverse events (AE) | Up to 6 years from study entry | Percentage of patients experiencing grade 3 or higher AEs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All grade 1 and 2 toxicities observed in \> 5% of participants and deemed related to study drug will be reported. |
| Primary | Pharmacokinetic (PK) parameter: systemic exposure | Up to Cycle 3 (each cycle lasts 28 days) | PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations. |
| Primary | PK parameter: drug clearance | Up to Cycle 3 (each cycle lasts 28 days) | PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations. |
| Primary | PK parameter: half-life | Up to Cycle 3 (each cycle lasts 28 days) | PK parameters of nirogacestat will be defined to quantify systemic exposure, drug clearance, terminal half-life and other pharmacokinetic characteristics. These PK parameters will be summarized with descriptive statistics, including means, medians, ranges, and standard deviations. |
| Secondary | Objective response rate | Up to 24 months | Defined by the rate of a complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Other | CTNNB1 and APC gene mutations and genomic signatures | Up to 2 years | The chi-square test will be used to assess the correlation of CTNNB1 and APC gene mutations and genomic signatures with tumor response, and the long-rank test will be used to assess the correlation of CTNNB1 and APC gene mutations and genomic signatures with PFS. |
| Other | Changes in the levels of each of the lymphocyte subsets and immunoglobulins | Up to 2 years | Lymphocyte subsets include CD3 (total T cells), CD3+CD4+ (T helper cells), CD3+CD8+ (T cytotoxic cells), CD3+HLA-DR+ (activated T cells) percentages and absolute counts and CD4:CD8 ratio. The chi-square test will be used to assess the correlation of the levels of lymphocyte and immunoglobulin with tumor response, and the Cox regression will be used to assess the correlation of the levels of lymphocyte and immunoglobulin with PFS. |
| Other | Response assessments by the RECIST criteria | Up to 2 years | Assesses tumor response based primarily on changes in measurable tumor lesions on imaging using RECIST 1.1. |
| Other | Response assessment by the World Health Organization (WHO) criteria | Up to cycle 2 years | Assesses tumor response using the product of two perpendicular tumor measurements according to the WHO criteria. |
| Other | Patient reported outcomes (PROs) | Up to 2 years | The chi-square test will be used to assess the correlation of PROs summary scores with tumor response, and the Cox regression will be used to assess the correlation of PROs summary scores with PFS. Correlation between PRO summary scores using Patient Reported Outcomes Measurement Information System and GOunder/DTRF DEsmoid Symptom/Impact Scale will be assessed by performing inferences on the Pearson correlation coefficients. |
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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