Trial · NCT01154140
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to death or last date known alive for those not known to have died (up to 72 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Overall Survival Probability at Month 12 and 18 | Month 12, 18 | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | percent probability | NUMBER |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) Based on IRR | From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here Overall number of participants analyzed (N) signifies participants with objective tumor response and were evaluable for this outcome measure. | weeks | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) Based on IRR | Randomization to first documentation of objective tumor response (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here N signifies participants with objective tumor response and were evaluable for this outcome measure. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control at Week 12 Based on IRR | Week 12 | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) Based on IRR | Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Time to Intracranial Progression (IC-TTP) Based on IRR | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Time to Extracranial Progression (EC-TTP) Based on IRR | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to follow up period (up to 72 months) | The safety analysis population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to follow up period (up to 72 months) | The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) According to Maximum Severity | Baseline up to follow up period (up to 72 months) | The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. | percentage of participants | NUMBER |
| SECONDARY | Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182 | Predose at Day 1 of Cycle 2, 3 and 5 | Pharmacokinetic concentration population included all participants in the safety analysis population who had at least 1 plasma concentration of crizotinib or its metabolite.N=participants evaluable for this measure.Number of participants analyzed(n)=participants evaluable at specified time points.This analysis was performed in crizotinib arm only. | nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants | 28 days prior to day 1 of study treatment | The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7). | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) | The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7). Here, n signifies participants who were evaluable at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough | From randomization of treatment up to deterioration while on study treatment (up to 35 months) | The patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment. | months | MEDIAN |
| SECONDARY | Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) | The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) | The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) | Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) | The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment. | units on a scale | MEAN |
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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