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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02156895
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):

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®.

Condition or disease
Advanced Renal Cell Carcinoma

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : August 21, 2021

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: bimonthly up to 24 months ]
    Tumor response based on RECIST 1.1

  2. 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

  3. 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)

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korea who has a disease for which Axitinib is indicated

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02156895

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Contact: Pfizer Call Center 1-800-718-1021

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Korea, Republic of
Pfizer Tower Recruiting
Seoul, Korea, Republic of, 04631
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT02156895    
Other Study ID Numbers: A4061075
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (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:
Keywords provided by Pfizer:
Korean PMS of Axitinib
Metastatic RCC ; 2nd line only
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases