A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 46
- 主要终点
- Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
研究概览
简要总结
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
- •Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF)
- •For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug
- •For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
排除标准
- •Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
- •Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
- •Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
- •Pregnant or breastfeeding women
- •Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study
- •Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
- •Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
- •Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the participant before trial entry
研究组 & 干预措施
Alectinib
Participants will receive alectinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
干预措施: Alectinib (Drug)
Crizotinib
Participants will receive crizotinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
干预措施: Crizotinib (Drug)
结局指标
主要结局
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
时间窗: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Selected safety laboratory parameters include alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, alkaline phosphatase (ALP), and blood creatine phosphokinase (CPK). Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy is considered clinically significant.
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
时间窗: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events of special interest are cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of an infectious agent by study drug.
次要结局
- Number and Causes of Death Occurring on Study(From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment))