A Study to Learn More About Tukysa Once it is Out in the Korean Market

Sponsor
Pfizer
Study ID
NCT06873191
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea. This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.

Key Dates

First listed
Mar 12, 2025
Start date
Jan 1, 2027
Status verified
Nov 2025
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
600 participants (estimated)

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year. ]

Central Contacts

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