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Trial record 1 of 1 for:    NCT02156895
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Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

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ClinicalTrials.gov Identifier: NCT02156895
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 6, 2014
First Posted Date June 5, 2014
Last Update Posted Date February 9, 2021
Actual Study Start Date July 17, 2018
Estimated Primary Completion Date August 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2019)
Adverse Event incidence [ Time Frame: bimonthly up to 24 months ]
The clinical nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; outcome and possible causality will be monitored in this study.
Original Primary Outcome Measures
 (submitted: June 3, 2014)
Safety [ Time Frame: bimonthly up to 24 months ]
The clinical nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; outcome and possible causality will be monitored in this study.
Change History
Current Secondary Outcome Measures
 (submitted: June 22, 2019)
  • Tumor Response [ Time Frame: bimonthly up to 24 months ]
    Tumor response based on RECIST 1.1
  • Objective Response Rate (ORR) [ Time Frame: bimonthly up to 24 months ]
    ORR(Objective Response Rate) : the proportion of patients who have a partial or complete response to therapy
  • Progression Free Survival (PFS) within limited follow-up period [ Time Frame: bimonthly up to 24 months ]
    Progression free survival (PFS) within limited follow up period due to limitation of study design (observation, non-interventional)
  • Time To Progression (TTP) [ Time Frame: bimonthly up to 24 months ]
    defined as the time to progression is one way to see how well a new treatment works
Original Secondary Outcome Measures
 (submitted: June 3, 2014)
  • Tumor Response [ Time Frame: bimonthly up to 24 months ]
    Tumor response based on RECIST 1.1
  • Objective Response Rate (ORR) [ Time Frame: bimonthly up to 24 months ]
  • Progression Free Survival (PFS) [ Time Frame: bimonthly up to 24 months ]
    Progression free survival (PFS) within limited follow up period
  • Duration of Response (DR) [ Time Frame: bimonthly up to 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 (REGISTERED)
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021