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

Last updated on October 16, 2019

FOR MORE INFORMATION
Study Location
Pfizer Tower
Seoul, , 04631 Korea, Republic of
Contact
1-800-718-1021
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

NCT02156895
Pfizer
Recruiting
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

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[email protected]

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Advanced Renal Cell Carcinoma
NCT02156895
All Genders
18+
Years
Seoul,
Descriptive Information
Brief TitlePost Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
Official TitlePost Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta®
Brief SummaryThe objective of this study is to monitor the usage of INLYTA® in real practice within label, including the adverse events associated with INLYTA®.
Detailed DescriptionThis 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationKorea who has a disease for which Axitinib is indicated
ConditionAdvanced Renal 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 StatusRecruiting
Estimated Enrollment
 (submitted: July 31, 2018)
100
Original Estimated Enrollment
 (submitted: June 3, 2014)
600
Estimated Study Completion DateAugust 21, 2021
Estimated Primary Completion DateAugust 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02156895
Other Study ID NumbersA4061075
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

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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