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

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NCT02533258

Last updated on November 20, 2019
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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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 TitlePost-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Official TitlePost-marketing Surveillance Study To Observe Inlyta (Registered) Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Brief SummaryThis 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 DescriptionThis 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationadvanced renal cell carinoma with disease progression on sunitinib or interferon
ConditionRenal Cell Carcinoma
InterventionNot Provided
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: May 11, 2017)		13
Original Estimated Enrollment
 (submitted: August 24, 2015)		1
Actual Study Completion DateMay 12, 2016
Actual Primary Completion DateMay 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/GenderNot Provided
Ages18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02533258
Other Study ID NumbersA4061076
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 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

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Contact

[email protected]

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