Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies
- Conditions
- Head and Neck CancerBreast Cancer
- Interventions
- Registration Number
- NCT05226871
- Lead Sponsor
- Pfizer
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 4 Palbociclib Palbociclib plus Letrozole Arm 3 Palbociclib Palbociclib plus Fulvestrant Arm 3 Fulvestrant Palbociclib plus Fulvestrant Arm 2 Cetuximab Palbociclib plus Cetuximab Arm 1 Cetuximab Cetuximab Arm 2 Palbociclib Palbociclib plus Cetuximab Arm 4 Letrozole Palbociclib plus Letrozole
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
UCSF Medical Center at Mission Bay
🇺🇸San Francisco, California, United States
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The First hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Scroll for more (12 remaining)UCSF Medical Center at Mission Bay🇺🇸San Francisco, California, United States