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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Head and Neck Cancer
• Intervention / Treatment: Drug: Cetuximab; Drug: Palbociclib; Drug: Fulvestrant; Drug: Letrozole

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • Recruiting
      • National Cancer Center
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06351
      • Recruiting
      • Samsung Medical Center
• Mexico
  • Nuevo LEÓN
    • Monterrey, Nuevo LEÓN, Mexico, 64460
      • Recruiting
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
• Ukraine
  • Dnipro, Ukraine, 49102
    • Recruiting
    • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
  • Ivano-Frankivsk, Ukraine, 76000
    • Recruiting
    • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
  • Chernivetska Oblast
    • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
      • Recruiting
      • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"
• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Medical Center at Mission Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; Cetuximab	Drug: Cetuximab; Intravenous (IV) infusion
Experimental: Arm 2; Palbociclib plus Cetuximab	Drug: Cetuximab; Intravenous (IV) infusion; Drug: Palbociclib; oral; Other Names: IBRANCE
Other: Arm 3; Palbociclib plus Fulvestrant	Drug: Palbociclib; oral; Other Names: IBRANCE; Drug: Fulvestrant; Intramuscular (IM)
Other: Arm 4; Palbociclib plus Letrozole	Drug: Palbociclib; oral; Other Names: IBRANCE; Drug: Letrozole; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)	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.	Baseline up to 28 days after last dose of study intervention

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Estimated): April 19, 2026
• Study Completion (Estimated): April 19, 2026

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hormone Receptor Positive Advanced Breast Cancer; Squamous Cell Carcinoma of the Head and Neck
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Letrozole; Fulvestrant; Palbociclib; Cetuximab
• Other Study ID Numbers: A5481173; 2021-005735-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No