NCT05226871

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

A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Breast Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib	oral
DRUG	Cetuximab	Intravenous (IV) infusion
DRUG	Fulvestrant	Intramuscular (IM)
DRUG	Letrozole	oral

Timeline

• Start date: 2022-07-07
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-02-07
• Last updated: 2025-11-25

Locations

23 sites across 7 countries: United States, China, Mexico, South Korea, Taiwan, Thailand, Ukraine

Regulatory

• FDA-regulated drug study