Trial · NCT04772235
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events (AEs) | Throughout the study period. Approximately 48 months | Number of patients experiencing AEs, both non treatment related and treatment related, classified by severity and graded according to the NCI CTCAE v5.0 |
| Primary | Incidence of Dose limiting toxicities (DLTs) | During the treatment cycle 1, 21 days | Number of patients experiencing AEs that have been predefined as DLTs: Toxicities resulting in an excessive number of missed doses, Hematologic, renal, hepatic toxicities grade ≥ 3; during the DLT observation period (Cycle 1, 21 days). Only patients in the Part A (dose escalation) of the study. |
| Secondary | Objective response rate (ORR) | Throughout the study period. Approximately 48 months | The ORR will be defined as the proportion of patients with complete response (CR) or partial response (PR). A confirmed response is a response that persists on a repeat-imaging performed at least 4 weeks after initial documentation of the response. Patients with a confirmed objective response (CR or PR) will be referred to as responders. Non-responders will include patients without a confirmed objective response, stable disease (SD), not evaluable (NE), or progression disease (PD). Blinded independent central review (BICR)-confirmed ORR will serve as the secondary (optional) analysis. |
| Secondary | Complete response rate (CR) | Throughout the study period. Approximately 48 months | Number of patients that achieve a confirmed complete response according to RECIST 1.1 criteria. (PR). A confirmed response is a response that persists on a repeat-imaging performed at least 4 weeks after initial documentation of the response. |
| Secondary | Partial response rate (PR) | Throughout the study period. Approximately 48 months | Number of patients that achieve a confirmed partial response according to RECIST 1.1 criteria. (PR). A confirmed response is a response that persists on a repeat-imaging performed at least 4 weeks after initial documentation of the response. |
| Secondary | Clinical Benefit Rate (CBR) | Throughout the study period. Approximately 48 months | The CBR will be defined as the proportion of patients with CR, PR, or stable disease. Stable disease refers to a condition where the tumor is neither increasing nor decreasing in extent or severity for at least 6 weeks after the first dose of repotrectinib, per RECIST, v1.1. The CBR and its 95% CI will be estimated using Clopper-Pearson exact confidence interval (CI). |
| Secondary | Duration of Response (DoR) | Throughout the study period. Approximately 48 months | The DOR will be defined from the first date of objective response (either CR or PR) to the first documentation of radiographically-confirmed disease progression, per RECIST v1.1 guideline and will be censored by the last tumor assessment date for patients without radiologically-confirmed disease progression. The DOR will be calculated only for patients with a confirmed, objective tumor response (PR or CR). |
| Secondary | Progression free survival (PFS) | Throughout the study period. Approximately 48 months | Progression-free survival (PFS) will be defined as the time from the first dose of repotrectinib to the first radiographically-confirmed case of disease progression or to death due to any cause, whichever occurs first. Investigator assessment will serve as the primary efficacy for radiographically-confirmed PFS. BICR-confirmed PFS will serve as the secondary (optional) analysis |
| Secondary | Overall survival (OS) | Throughout the study period. Approximately 48 months | Overall survival (OS) will be defined as the time from first dose of repotrectinib to the date of death, or lost to follow up, whichever occurs first. |
| Secondary | Intracranial Objective Response Rate (IC-ORR) | Throughout the study period. Approximately 48 months | IC-ORR is defined as the proportion of patients with intracranial target lesions that are measurable at Baseline who achieve a PR or CR, per RECIST, v.1.1. |
| Secondary | Maximum plasma concentration (Cmax) | on 6 occasions for each patient throughout study: cycle 1 day -1, cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, cycle 2 day 1 and cycle 5 day 1 | Pharmacokinetics (PK) parameter of osimertinib and repotrectinib. Cmax is the maximum (or peak) serum concentration that the drug achieves in blood after the drug has been administered. |
| Secondary | Tmax | on 6 occasions for each patient throughout study: cycle 1 day -1, cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, cycle 2 day 1 and cycle 5 day 1 | Pharmacokinetics (PK) parameter of osimertinib and repotrectinib. Tmax is defined as the time of maximum concentration of the drug in blood observed after a drug dose administration. |
| Secondary | Area under the curve (AUC) | on 6 occasions for each patient throughout study: cycle 1 day -1, cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, cycle 2 day 1 and cycle 5 day 1 | Pharmacokinetics (PK) parameter of osimertinib and repotrectinib. AUC is the definite integral of a curve that describes the variation of a drug concentration in blood plasma as a function of time. AUC reflects the actual body exposure to drug after administration of a dose. |
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/NCT04772235/registered