Trial · NCT02614794
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR) | 34.6 months | Defined as the time from the date of randomization to the date of documented disease progression. |
| Secondary | PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR | 34.6 months | Defined as the time from the date of randomization to the date of documented disease progression. |
| Secondary | Overall Survival (OS) at Time of Primary Analysis | 35.9 months | Defined as time from randomization to death from any cause |
| Secondary | Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR | 34.6 months | Defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR). |
| Secondary | ORR Per RECIST 1.1 as Determined by Investigator Assessment | 34.6 months | Defined as achieving a best overall response of confirmed CR or confirmed PR. |
| Secondary | PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis | 34.6 months | Defined as the time from the date of randomization to the date of documented disease progression |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR | 24.6 months | Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first. |
| Secondary | DOR Per RECIST 1.1 as Determined by Investigator Assessment | 33.2 months | Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first. |
| Secondary | Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1 | 34.6 months | Clinical benefit was defined as achieving stable disease (SD) or non-complete response (CR)/non-progressive disease (PD) for at least 6 months or a best overall response of confirmed CR or confirmed partial response (PR). |
| Secondary | CBR Per RECIST 1.1 as Determined by Investigator Assessment | 34.6 months | Clinical benefit was defined as achieving stable disease (SD) or non-CR/non-PD for at least 6 months or a best overall response of confirmed CR or confirmed PR. |
| Secondary | Incidence of Adverse Events (AEs) at Time of Primary Analysis | 36.1 months | As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria. |
| Secondary | Frequency of Dose Modifications | 35.1 months | |
| Secondary | Incidence of Health Resources Utilization | 36.1 months | Cumulative incidence of health resource utilization, including length of stay, hospitalizations, and ER visits using the EQ-5D-5L questionnaire. |
| Secondary | Pharmacokinetic Measure: Ctrough of Tucatinib | 3.5 months | Individual plasma tucatinib concentrations at each sampling time |
| Secondary | Pharmacokinetic Measure: ONT-993 | 3.5 months | Individual plasma primary metabolite concentrations at each sampling time |
| Secondary | Overall Survival (OS) at Time of Final Analysis | Up to 60.1 months | Defined as time from randomization to death from any cause |
| Secondary | PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Final Analysis | Up to 58.0 months | Defined as the time from the date of randomization to the date of documented disease progression |
| Secondary | Incidence of Adverse Events (AEs) at Time of Final Analysis | Up to 60.1 months | As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria. |
| Secondary | Frequency of Dose Modifications at Time of Final Analysis | Up to 60.1 months |
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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