Trial · NCT02075840
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) by Investigator Assessment | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
| PRIMARY | Percentage of Participants With PFS Event by Investigator Assessment | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | PFS Independent Review Committee (IRC)-Assessed | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PFS Event by IRC | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria | Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators | First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until death (up to 43 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Percentage of Participants With OS Event | From randomization until death (up to 43 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline). | Percentage of Participants | NUMBER |
| SECONDARY | CNS DOR IRC-assessed According to RECIST v1.1 Criteria | First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events | Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm | Safety (SAF) population included all participants who received at least one dose of any study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Area Under The Concentration-Time Curve (AUC) of Alectinib | Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Alectinib | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Cmax (Tmax) of Alectinib | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | hours | MEDIAN |
| SECONDARY | AUC of Alectinib Metabolite | Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Alectinib Metabolite | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax of Alectinib Metabolite | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | hours | MEDIAN |
| SECONDARY | Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30) | Baseline, every 4 weeks until disease progression (up to 33 months) | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | months | MEDIAN |
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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