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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 March 25, 2020

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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Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population advanced renal cell carinoma with disease progression on sunitinib or interferon
Condition Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2017)
13
Original Estimated Enrollment
 (submitted: August 24, 2015)
1
Actual Study Completion Date May 12, 2016
Actual Primary Completion Date May 12, 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender Not Provided
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02533258
Other Study ID Numbers A4061076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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