Trial · NCT00932893
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | Full analysis set (FAS) included all participants who were randomized to study treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization until death (up to 4.5 years) | FAS included all participants who were randomized to study treatment. | months | MEDIAN |
| SECONDARY | Overall Survival Probability at Months 6 and 12 | Month 6, 12 | FAS included all participants who were randomized to study treatment. | percent chance of survival | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | FAS included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control at Week 6 | Week 6 | FAS included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control at Week 12 | Week 12 | FAS included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response. | weeks | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response. | weeks | MEDIAN |
| SECONDARY | Plasma Concentration of Crizotinib | Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5 | Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here N (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Categorical Maximum QTcF for Crizotinib | Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2 | ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement. | participants | NUMBER |
| SECONDARY | Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins | Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks) | The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment). | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough | Baseline up to end of treatment (up to 112 weeks) | Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment. | months | MEDIAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for specified time points for each arm group, respectively. | units on a scale | MEAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13) | Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for specified time points for each arm group, respectively. | units on a scale | MEAN |
| SECONDARY | European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS) | Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks) | FAS included all participants who were randomized to study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for specified time points for each arm group, respectively. | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00932893/outcomes