Palbociclib Continuation Study for Participants Continuing From Pfizer-sponsored Palbociclib Clinical Studies

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05226871

Collaborator

(none)

Enrollment

Location

Arms

45.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A continuation study for participants deriving clinical benefit from palbociclib parent studies

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Head and Neck Cancer	Drug: Palbociclib Drug: Cetuximab Drug: Fulvestrant Drug: Letrozole	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 7, 2022

Anticipated Primary Completion Date :

Apr 19, 2026

Anticipated Study Completion Date :

Apr 19, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1 Cetuximab	Drug: Cetuximab Intravenous (IV) infusion
Experimental: Arm 2 Palbociclib plus Cetuximab	Drug: Palbociclib oral Other Names: IBRANCE Drug: Cetuximab Intravenous (IV) infusion
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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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