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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

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
Official Title: POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF INLYTA (REGISTERED)
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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02156895


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Pfizer Tower Recruiting
Seoul, Korea, Republic of, 04631
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov 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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
Korean PMS of Axitinib
Metastatic RCC ; 2nd line only
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases