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

Pfizer

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer; Head and Neck Cancer

Treatments: Drug: Fulvestrant; Drug: Palbociclib; Drug: Letrozole; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226871

A5481173

2021-005735-22 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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)

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

Arm 1

Other group

Description:

Cetuximab

Treatment:

Drug: Cetuximab

Arm 2

Experimental group

Description:

Palbociclib plus Cetuximab

Treatment:

Drug: Cetuximab

Drug: Palbociclib

Arm 3

Other group

Description:

Palbociclib plus Fulvestrant

Treatment:

Drug: Palbociclib

Drug: Fulvestrant

Arm 4

Other group

Description:

Palbociclib plus Letrozole

Treatment:

Drug: Letrozole

Drug: Palbociclib