Trial · NCT05372640
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 | Maximum tolerated dose or recommended phase 2 dose (Phase I dose escalation) | During the first cycle of therapy (28 days) | The toxicity of the combination will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0 criteria. |
| Primary | Incidence of adverse events (Phase I dose expansion) | Up to 5 years | Safety will be reported with descriptive statistics. Toxicity will be graded according to National Cancer Institute CTCAE, v5.0. Toxicities will be summarized by maximum grade and by treatment arm. Incidence rate of each toxicity will be reported with 95% exact confidence intervals. |
| Primary | Overall response rate (Phase I dose expansion) | Up to 5 years | Will be graded as complete response (CR), partial response (PR), stable disease (SD) and progressive disease. |
| Primary | Clinical benefit rate (CBR) (Phase I dose expansion) | Up to 5 years | Clinical benefit is defined as CR, PR or SD \>= 24 weeks according to Response Evaluation Criteria in Solid Tumors 1.1. CBR will be reported with 90% exact confidence intervals. |
| Primary | Duration of response (DoR) (Phase I dose expansion) | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | Median DoR will be reported with ranges. |
| Primary | Time to response (Phase I dose expansion) | From the time initiation of therapy to the time measurement criteria are met for CR or PR (whichever is first recorded), assessed up to 5 years | |
| Primary | Overall survival (Phase I dose expansion) | From study enrollment until death due to any cause, assessed up to 5 years | |
| Primary | Progression free survival (Phase I dose expansion) | From study enrollment until the identification of disease progression or death, assessed up to 5 years | |
| Secondary | Pharmacokinetics (PK) | Up to 5 years | Designed the PK sampling to enable simultaneous estimation of individual pharmacokinetic parameters of abemaciclib, ZEN003694, and their respective metabolites using nonlinear mixed effects modeling. Will compare the ratio of observed/historical 90% confidence interval of abemaciclib exposure. |
| Secondary | Thymidine kinase (TK) | Up to 5 years | Will compare exposures of abemaciclib and abemaciclib metabolites to TK activity at cycle 1 day 15 and beyond and also change in TK activity versus clinical outcomes. |
| Other | Analysis of ATAC-sequence data | Up to 5 years | An internal pipeline will be used to perform quality control and data pre-processing. Burrows-Wheeler Aligner will be used for read mapping against the hg19 map using default parameters. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05372640/registered