Clinical trial NCT02156895: Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
Official title: POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF INLYTA (REGISTERED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Renal Cell Carcinoma
Keywords: Korean PMS of Axitinib
Metastatic RCC ; 2nd line only
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korea who has a disease for which Axitinib is indicated

Brief summary: The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.

Detailed description: Investigators can choose any patient who is within the scope of I/E criteria

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as advanced RCC after failure of one prior systemic therapy.

Exclusion Criteria:

* Any patient who does not agree that Pfizer or companies working on behalf of Pfizer can use his/her information.
* Patients with hypersensitivity to axitinib or to any other component of INLYTA® .
* Patients under 18.
* Pregnant women.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Duration of Adverse Events
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events by Their Severity
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events by Their Outcome
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events by Their Seriousness Criteria
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events by Their Causality to Inlyta
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events by Their Other Causality
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events by Their Action Taken With Study Drug
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events According to Demographic Characteristics
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events According to Other Baseline Characteristics
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With AEs and ADRs - Special Participant Population
timeFrame: From first dose of Inlyta or time of the participant's informed consent through the end of the observation period of the study, which included at least 28 calendar days post last dose of drug under study (observation period for the study was of 9 years)
measure: Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: From first dose of Inlyta up to first documented CR, PR, PD or SD, during observation period of the study of 9 years
measure: Number of Participants With Objective Response
timeFrame: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years
measure: Number of Participants With Objective Response According to Demographic Characteristics
timeFrame: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years
measure: Number of Participants With Objective Response According to Other Baseline Characteristics
timeFrame: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years
measure: Number of Participants With Objective Response - Multivariate Logistic Regression Analysis
timeFrame: From first dose of Inlyta up to first documented CR or PR, during observation period of the study of 9 years
measure: Progression Free Survival (PFS)
timeFrame: From first dose of Inlyta up to first documented tumor progression or death, whichever occurred first, during observation period of the study of 9 years
measure: Time to Progression (TTP)
timeFrame: From first dose of Inlyta up to first documented disease progression or latest follow-up, during observation period of the study of 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Tower
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: