A Post Marketing Surveillance on Piqray in Korea

November 20, 2023 updated by: Novartis Pharmaceuticals

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Novartis Investigative Site
      • Busan, Korea, Republic of, 602-030
        • Recruiting
        • Novartis Investigative Site
      • Daejeon, Korea, Republic of, 302-241
        • Recruiting
        • Novartis Investigative Site
      • Jeollanam, Korea, Republic of, 519763
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 158-710
        • Recruiting
        • Novartis Investigative Site
    • Chungcheongnam Do
      • Cheonan Si, Chungcheongnam Do, Korea, Republic of, 31116
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi Do
      • Deogyang Gu Goyang Si, Gyeonggi Do, Korea, Republic of, 10475
        • Recruiting
        • Novartis Investigative Site
      • Suwon si, Gyeonggi Do, Korea, Republic of, 16499
        • Recruiting
        • Novartis Investigative Site
    • Seoul
      • Songpa-gu, Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are going to receive Piqray per locally approved label are eligible and will be prescribed with Piqray under routine medical practice.

Description

Inclusion Criteria:

Subjects eligible for this study must meet all of the following criteria:

  1. Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer.
  2. Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label.
  3. Patients who are willing to provide written informed consent

Exclusion Criteria:

Subjects eligible for this study must not meet the following criteria:

  1. Patients with contraindication according to prescribing information for Piqray in Korea.

    - Severe hypersensitivity to Piqray or to any of its components

  2. Female subjects who are pregnant and nursing (lactating)
  3. Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
  4. Participants who receive or are going to receive any investigational medicine during surveillance period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Piqray
Patients prescribed with Piqray
Other: Piqray
There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Other Names:
  • Alpelisib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AEs
Time Frame: 24 weeks
Incidence of AEs, including SAEs and ADRs
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rates (ORRs)
Time Frame: Up to 24 weeks
Objective response rates (ORRs). ORR is defined as the proportion of treated patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR) according to the response evaluation criteria in solid tumors (RECIST) version 1.1.
Up to 24 weeks
Prescription dose of Piqray in combination with fulvestrant
Time Frame: Up to 24 weeks
Prescription dose of Piqray in combination with fulvestrant
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Estimated)

May 12, 2027

Study Completion (Estimated)

May 12, 2027

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBYL719CKR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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