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Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02533258
Pfizer
Completed
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice

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Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Post-marketing Surveillance Study To Observe Inlyta (Registered) Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
advanced renal cell carinoma with disease progression on sunitinib or interferon
Renal Cell Carcinoma
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 12, 2016
May 12, 2016   (Final data collection date for primary outcome measure)

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.
Not Provided
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02533258
A4061076
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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