An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects With Relapsed/Refractory B-cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)
研究概览
简要总结
The primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the prior dosing regimen from the 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
- •Currently enrolled in a prior tirabrutinib study
- •Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
- •Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
- •Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
- •Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
- •Lactating females must agree to discontinue nursing before the study drug is administered
- •Ability and agreement to attend protocol-specified visits at the study site
- •Able to comprehend and willing to sign the informed consent form
排除标准
- •Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tirabrutinib 40 mg once daily (CLL)
Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 40 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 80 mg once daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 160 mg once daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 320 mg once daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 400 mg once daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 500 mg once daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 600 mg once daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 300 mg twice daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 160 mg once daily (NHL)
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 320 mg once daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 480 mg once daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
Tirabrutinib 600 mg once daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.
干预措施: Tirabrutinib (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)
时间窗: First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study
Treatment-emergent AEs were defined as one or both of the following: * Any AEs with an onset date on or after the study drug start date of parent study and no later than 30 days after permanent discontinuation of study drug in this rollover study; * Any AEs leading to premature discontinuation of study drug.
Percentage of Participants Who Experienced Treatment-Emergent Marked Laboratory Abnormalities
时间窗: First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study
Treatment-emergent marked laboratory abnormalities were defined as values that increase from baseline by at least 3 toxicity grades at any postbaseline time point, up to and including the date of the last dose of study drug plus 30. If the relevant baseline laboratory value is missing, any Grade 3 or 4 values observed within the timeframe specified above will be considered treatment-emergent marked abnormalities. Laboratory assessments included tests for Chemistry, Hematology, Coagulation and Urinalysis.
次要结局
- Overall Survival (OS)(From first dose of tirabrutinib in the parent study (NCT01659255) until death from any cause up to 99 months)
- Progression-free Survival (PFS)(From first dose of tirabrutinib in the parent study (NCT01659255) to the first documentation of disease progression or death from any cause up to 99 months)
- Overall Response Rate (ORR)(Up to 39 months in parent study and up to 60 months in rollover study)
- Duration of Response (DOR)(From first documentation of CR or PR to the first documentation of disease progression or death from any cause up to 39 months in parent study and up to 60 months in the rollover study)