Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

Last updated: February 2, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Treatment

Letrozole

Cetuximab

Fulvestrant

Clinical Study ID

NCT05226871
A5481173
2021-005735-22
  • Ages > 18
  • All Genders

Study Summary

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:

  • Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study

  • Must agree to follow the reproductive criteria

  • Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures

  • Can give signed informed consent documents

Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any participant who is receiving study treatment and deriving clinical benefit asdetermined by the investigator in a Pfizer-sponsored palbociclib Parent Study

  • Participants must agree to follow the reproductive criteria

  • Participants who are willing and able to comply with all scheduled visits, treatmentplans, and other study procedures

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent document and protocol

Exclusion

Exclusion Criteria:

  • Any medical reason that, in the opinion of the investigator or sponsor, precludesthe participant from inclusion in the study

Study Design

Total Participants: 35
Treatment Group(s): 4
Primary Treatment: Letrozole
Phase: 2
Study Start date:
July 07, 2022
Estimated Completion Date:
December 31, 2026

Study Description

This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • The First hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110167
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, 100021
    China

    Active - Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo LEÓN 64460
    Mexico

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704302
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital

    Taipei, 10449
    Taiwan

    Active - Recruiting

  • Faculty of Medicine, Ramathibodi Hospital, Mahidol University

    Ratchathewi, Bangkok 10400
    Thailand

    Active - Recruiting

  • Department of Medicine, Faculty of Medicine Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"

    Chernivtsi, Chernivetska Oblast 58013
    Ukraine

    Active - Recruiting

  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

    Dnipro, 49102
    Ukraine

    Active - Recruiting

  • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76000
    Ukraine

    Site Not Available

  • UCSF Medical Center at Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.