NCT03770000已完成1 期
An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma
Rhizen Pharmaceuticals SA15 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年3月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 15
- 主要终点
- Number of Participants With and Without Dose Limiting Toxicities (DLTs)
研究概览
简要总结
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Pathologically confirmed T-cell lymphomas at the enrolling institution.
- •Disease status as defined as relapsed or progressed patients who have received at least one systemic therapy.
- •The patients should have received NOT more than three prior systemic combination chemotherapies
- •PTCL patients must have measurable disease defined as at least one bidimensional measurable lesion with minimum measurement of > 1.5 cm in the longest diameter.
- •Must have ECOG performance status ≤ 2
- •Adequate bone marrow, liver and renal function in line with below mentioned laboratory requirements.
- •Hemoglobin ≥8.0 g/dL
- •Absolute neutrophil count (ANC) ≥1,000/µL
- •Platelet count ≥75,000/μL
- •Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
- •AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN in case of liver involvement
- •Calculated creatinine clearance (CrCl) > 50 ml/min by Cockcroft-Gault formula
- •Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential.
- •Provide written informed consent prior to any study-specific screening procedures.
- •Willingness and capability to comply with the requirements of the study
排除标准
- •Patient receiving anticancer therapy including any investigational therapy ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D
- •Patient who discontinued prior therapy with PI3K inhibitors or HDAC inhibitors due to drug toxicity.
- •PTCL patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D
- •CTCL patients with the history of Allo-SCT will be excluded.
- •Patient with medical conditions requiring the use of systemic immunosuppressive medications (> 20 mg/day of prednisone or equivalent).
- •Severe bacterial, viral or mycotic infection requiring systemic treatment.
- •Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV) infection.
- •Known seropositive requiring anti-viral therapy for hepatitis B virus (HBV) infection OR evidence of active hepatitis B infection as defined by detectable viral load if the antibody tests are positive..
- •Known seropositive requiring anti-viral therapy for hepatitis c virus (HCV) infection OR patients with positive hepatitis C virus Ab.
- •Subjects with active EBV unrelated to underlying lymphoma (positive serology for anti- EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection.
- •Subject with active CMV (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody and positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy.
- •Uncontrolled or significant cardiovascular disease including, but not limited to:
- •Congenital long QT syndrome.
- •QTcF interval > 450 msec
- •Myocardial infarction or stroke/TIA within the past 6 months
- •Uncontrolled angina within the past 3 months
- •Significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block (AV) block type II, 3rd degree AV block.
- •History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes),
- •History of other clinically significant heart disease (ie, cardiomyopathy, congestive heart failure with NYHA functional classification III-IV, pericarditis, significant pericardial effusion)
- •Requirement for daily supplemental oxygen therapy.
研究组 & 干预措施
Tenalisib+Romidepsin
Experimental
Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
干预措施: Tenalisib (Drug)
Tenalisib+Romidepsin
Experimental
Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
干预措施: Romidepsin (Drug)
结局指标
主要结局
Number of Participants With and Without Dose Limiting Toxicities (DLTs)
时间窗: 28 days
The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
次要结局
- Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination(12 weeks)
- Maximum Observed Plasma Concentration (Cmax)(8 days)
- Duration of Response (DoR) With Tenalisib and Romidepsin Combination(28 weeks)
研究者
研究点 (15)
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