An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)
概览
- 阶段
- 1 期
- 干预措施
- Tirabrutinib
- 疾病 / 适应症
- Non Hodgkins Lymphoma
- 发起方
- Gilead Sciences
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Percentage of Participants Experiencing Dose-Limiting Toxicities
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
研究者
入排标准
入选标准
- •Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate.
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
排除标准
- •Central nervous system (CNS) lymphoma.
- •Women who are pregnant or lactating.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tirabrutinib 400 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 20 mg Once Daily (CLL)
Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 40 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 80 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 160 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 320 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 500 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 600 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 300 mg Twice Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
干预措施: Tirabrutinib
Tirabrutinib 20 mg Once Daily (NHL)
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 40 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
干预措施: Tirabrutinib
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
干预措施: Tirabrutinib
结局指标
主要结局
Percentage of Participants Experiencing Dose-Limiting Toxicities
时间窗: Day 1 through Day 28
Dose Limiting Toxicities (DLT) were defined as follows: * All Common Terminology Criteria (CTC) Grade 4 tirabrutinib related adverse events * All CTC Grade 3 tirabrutinib related adverse events, with the exception of the following: * CTC Grade 3 lymphocytosis considered an expected outcome of therapy Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT.
次要结局
- PK Parameter: AUCtau of Tirabrutinib(Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28)
- Overall Response Rate(Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months))
- Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib(Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28)