Trial · NCT02838420
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 | Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months) | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first. |
| Secondary | PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by an independent review committee, or to death from any cause, whichever occurred first. |
| Secondary | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1 | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Overall Survival Time | Baseline, until death (up to overall period of approximately 40 months) | |
| Secondary | Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events | Up to overall period of approximately 40 months | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Secondary | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months) | |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite | Baseline and Week 4 predose (within 2 hours before administration of study drug) | AUC was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time. |
| Secondary | Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite | Baseline and Week 4 predose (within 2 hours before administration of study drug) | Cmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time. |
| Secondary | Time to Cmax (Tmax) of Alectinib and Its Metabolite | Baseline and Week 4 predose (within 2 hours before administration of study drug) | Tmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time. |
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
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