Trial · NCT02127710
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (RECIST Version 1.1) | Up to 12 months | The primary outcome measure was Objective Response Rate (ORR), defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to Response Evaluation Criteria for Solid Tumours (RECIST) v1.1. |
| Primary | Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set | 12 Months | The primary outcome measure was ORR, defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to RECIST v1.1. |
| Primary | Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set | 12 Months | The primary outcome measure was ORR, defined as the proportion of patients with either a confirmed complete response/partial response by investigator assessment according to RECIST v1.1. |
| Secondary | Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set | Up to 12 months | |
| Secondary | Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set | Up to 12 months | |
| Secondary | Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set | Up to 12 months | |
| Secondary | Overall Survival Stratified by c-MET Status in the Safety Analysis Set | Up to 12 months | |
| Secondary | Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set | 12 Weeks (at 12 weeks timepoint) | 12 week summary for patients in the Efficacy analysis set, by MET status. The numbers of patients analysed represent the numbers evaluable at the 12 week timepoint. |
| Secondary | Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set. | 12 Weeks (at 12 week timepoint) | 12 week summary for patients in the Safety analysis set by MET Status. The number of patients analysed represent the number of evaluable patients at the 12 week timepoint. |
| Secondary | Duration of Response | Up to 12 months | Duration of Response is the time from the first documentation of confirmed complete response/partial response until the date of progression, or death in the absence of progression. There were 8 responders: one of whom subsequently progressed or died and seven of whom were still classified as responders at the time of data cut-off and were therefore censored. It was not possible to determine a median or 75th percentile. |
| Secondary | Peak Plasma Concentration of AZD6094 Following Single Dose | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
| Secondary | Time to Peak Plasma Concentration of AZD6094 After Single Dose | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
| Secondary | Apparent Volume of Distribution of AZD6094 Following Single Dose | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
| Secondary | Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
| Secondary | Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose (Time Zero to Last Measurement) | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
| Secondary | Apparent Total Clearance of AZD6094 From Plasma After Single Dose | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
| Secondary | Mean Residence Time of AZD6094 After Single Dose | 24 Hours | The number of patients analysed represent the number of evaluable PK parameters for this endpoint. |
| Secondary | Elimination Half-Life of AZD6094 After Single Dose | 24 Hours | The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02127710/registered