A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 46
- 主要终点
- Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
研究组 & 干预措施
Arm 2
Palbociclib plus Cetuximab
干预措施: Palbociclib (Drug)
Arm 3
Palbociclib plus Fulvestrant
干预措施: Palbociclib (Drug)
Arm 4
Palbociclib plus Letrozole
干预措施: Letrozole (Drug)
Arm 2
Palbociclib plus Cetuximab
干预措施: Cetuximab (Drug)
Arm 1
Cetuximab
干预措施: Cetuximab (Drug)
Arm 4
Palbociclib plus Letrozole
干预措施: Palbociclib (Drug)
Arm 3
Palbociclib plus Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs)
时间窗: 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.
次要结局
未报告次要终点