Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies
Primary Purpose
Breast Cancer, Head and Neck Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Palbociclib
Cetuximab
Fulvestrant
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Hormone Receptor Positive Advanced Breast Cancer, Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
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
Sites / Locations
- UCSF Medical Center at Mission Bay
- National Cancer CenterRecruiting
- Samsung Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"Recruiting
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City CouncilRecruiting
- Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional CouncilRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Other
Other
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Cetuximab
Palbociclib plus Cetuximab
Palbociclib plus Fulvestrant
Palbociclib plus Letrozole
Outcomes
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05226871
Brief Title
Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies
Official Title
A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
April 19, 2026 (Anticipated)
Study Completion Date
April 19, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Head and Neck Cancer
Keywords
Hormone Receptor Positive Advanced Breast Cancer, Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
Cetuximab
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Palbociclib plus Cetuximab
Arm Title
Arm 3
Arm Type
Other
Arm Description
Palbociclib plus Fulvestrant
Arm Title
Arm 4
Arm Type
Other
Arm Description
Palbociclib plus Letrozole
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Other Intervention Name(s)
IBRANCE
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Intramuscular (IM)
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
oral
Primary Outcome Measure Information:
Title
Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 28 days after last dose of study intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"
City
Chernivtsi
State/Province
Chernivetska Oblast
ZIP/Postal Code
58013
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
City
Ivano-Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A5481173
Description
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Learn more about this trial
Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies
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