Clinical trial NCT02533258: Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Official title: Post-marketing Surveillance Study To Observe Inlyta (Registered) Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 13
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced renal cell carinoma with disease progression on sunitinib or interferon

Brief summary: This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.

Detailed description: This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as advanced RCC by histology or cytology
* Patients using axitinib as therapy after failure of sunitinib or cytokine
* Patients received axitinib treatment and follow up in the health care center participating present registry
* Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available

Exclusion Criteria:

* Patients with first dose of axitinib earlier than 7th May 2013
* Patients with first dose of axitinib later than 30th June 2015.
* Patients participating in clinical research involving axitinib
* Patients with hypersensitivity to axitinib or to any other component of axitinib
* Patients under 18-year of age
* Pregnant women.

Primary outcomes:
measure: Duration of Axitinib Treatment
timeFrame: From initiation of axitinib treatment up to the end of the study (up to 40 months)
measure: Mean Daily Dose of Axitinib
timeFrame: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
measure: Duration of Response
timeFrame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
measure: Progression-Free Survival (PFS)
timeFrame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From initiation of axitinib treatment up to end of the study (up to 40 months)
measure: Number of Participants With Adverse Events (AEs) by Severity
timeFrame: From initiation of axitinib treatment up to end of the study (up to 40 months)
measure: Number of Participants With Treatment-Related Adverse Events (AEs)
timeFrame: From initiation of axitinib treatment up to end of the study (up to 40 months)
measure: Number of Participants Discontinued Due to Adverse Events (AEs)
timeFrame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: