Trial · NCT01360554
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Per Independent Radiologic Review. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Based on Investigator Review. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Based on Investigator Review in KRAS-WT Participants. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS). | From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Months | MEDIAN |
| SECONDARY | OS in KRAS-WT Participants. | From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months. | ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) Per Independent Radiologic Review. | From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Participants | NUMBER |
| SECONDARY | BOR Per Investigator Review. | From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Participants | NUMBER |
| SECONDARY | Duration of Response (DR) Based on Independent Radiologic Review. | From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response. | Months | MEDIAN |
| SECONDARY | DR Based on Investigator Review. | From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. | DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response. | Months | MEDIAN |
| SECONDARY | Trough Concentrations (Ctrough) of Dacomitinib. | Baseline up to Cycle 5 Day 1 | Participants treated with dacomitinib with at least one measured plasma concentration. | Trough Plasma Concentration (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Trough Concentrations (Ctrough) of PF-05199265. | Baseline up to Cycle 5 Day 1 | Participants treated with dacomitinib with at least one measured plasma concentration. | Trough Plasma Concentration (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Months | MEDIAN |
| SECONDARY | Mean and Difference in Mean 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) | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Units on a scale. | MEAN |
| SECONDARY | Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Units on a scale. | MEAN |
| SECONDARY | Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Units on a scale. | MEAN |
| SECONDARY | Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | 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/NCT01360554/outcomes