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

Phase 2

Recruiting

• Conditions: Head and Neck Cancer; Breast Cancer
• Interventions: Drug: Palbociclib; Drug: Fulvestrant; Drug: Cetuximab; Drug: Letrozole

• Registration Number: NCT05226871
• Lead Sponsor: Pfizer

Brief 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).

Detailed 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)

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-07-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Any participant who is receiving study treatment and deriving clinical benefit as determined 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, treatment plans, and other study procedures
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document and protocol

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Palbociclib	Palbociclib plus Letrozole
Arm 3	Palbociclib	Palbociclib plus Fulvestrant
Arm 3	Fulvestrant	Palbociclib plus Fulvestrant
Arm 2	Cetuximab	Palbociclib plus Cetuximab
Arm 1	Cetuximab	Cetuximab
Arm 2	Palbociclib	Palbociclib plus Cetuximab
Arm 4	Letrozole	Palbociclib plus Letrozole

Primary Outcome Measures

Name	Time	Method
Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)	Baseline up to 28 days after last dose of study intervention	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Trial Locations

Locations (22)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, China

Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council; 🇺🇦 Dnipro, Ukraine

Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council; 🇺🇦 Ivano-Frankivsk, Ukraine

UCSF Medical Center at Mission Bay; 🇺🇸 San Francisco, California, United States

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

The First hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"; 🇲🇽 Monterrey, Nuevo LEÓN, Mexico

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand

Department of Medicine, Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"; 🇺🇦 Chernivtsi, Chernivetska Oblast, Ukraine