Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

NCT02156895

Last updated date
Study Location
Pfizer Tower
Seoul, , 04631, Korea, Republic of
Contact
1-800-718-1021

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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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients diagnosed as advanced renal cell carcinoma (aRCC) after failure of one prior systemic therapy.

2. Patients to whom INLYTA® is first administered or patients who are already on INLYTA® during the study period

3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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


1. Any patient who does not agree that Pfizer and companies working with Pfizer use
his/her information


2. Patients with hypersensitivity to axitinib or to any other component of INLYTA®


3. Patients under 18


4. Pregnant women

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Advanced Information
Descriptive Information
Brief Title 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®
Brief Summary The objective of this study is to monitor the usage of INLYTA® in real practice within label, including the adverse events associated with INLYTA®.
Detailed Description This is observational, non-interventional multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Korea who has a disease for which Axitinib is indicated
Condition Advanced 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 Recruiting
Estimated Enrollment
 (submitted: July 31, 2018)
100
Original Estimated Enrollment
 (submitted: June 3, 2014)
600
Estimated Study Completion Date August 21, 2021
Estimated Primary Completion Date August 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients diagnosed as advanced renal cell carcinoma (aRCC) after failure of one prior systemic therapy.
  2. Patients to whom INLYTA® is first administered or patients who are already on INLYTA® during the study period
  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  1. Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information
  2. Patients with hypersensitivity to axitinib or to any other component of INLYTA®
  3. Patients under 18
  4. Pregnant women
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02156895
Other Study ID Numbers A4061075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019