NCT03212937已完成1 期
A Phase I Investigator Sponsored Trial of Selinexor (KPT-330), a Selective Inhibitor of Nuclear Export / SINE™ Compound and Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
National Cancer Centre, Singapore1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年7月1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
- 11
- 试验地点
- 1
- 主要终点
- Number of participants with treatment related dose limiting toxicity as assessed by NCI CTCAE v4.0
研究概览
简要总结
This is a single center, open-label, phase I trial with a standard 3+3 dose escalation schema to identify the maximum tolerated dose (MTD) of selinexor when combined with ICE. Once MTD is determined, there will be an expansion phase and tumor biopsies and peripheral blood will be taken pre and post selinexor to examine the study's biologic objectives.
详细描述
STUDY OBJECTIVES:
Primary:
• To determine the maximum tolerated dose (MTD) of selinexor when given in combination with a standard dose regimen of ifosfamide, carboplatin and etoposide (ICE) in patients with relapsed or refractory PTCL
Secondary:
- To assess the response rates (complete and partial), progression-free survival (PFS) and overall survival (OS) in patients with relapsed or refractory PTCL
- To estimate the feasibility of stem cell collection after selinexor and ICE
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed T or NK/T-cell lymphomas including the following histologies:
- •Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
- •Angioimmunoblastic T-cell lymphomas (AITL)
- •Anaplastic large cell lymphoma (ALCL)
- •Natural-killer/T-cell lymphoma (NKTL)
- •Patients must have received at least two cycles of one prior regimen administered with curative intent and one of the following:
- •failed to have achieve at least a partial response after 2 or more cycles
- •failed to achieve a complete response after 6 or more cycles
- •progressed after an initial response
- •For patients who have CD30+ anaplastic large cell lymphoma, they must have failed or are ineligible or intolerant of brentuximab vedotin
- •Patients must be age >18 years.
- •Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
- •Patients must have ECOG performance status of 0-2
- •Patients must have laboratory test results within these ranges:
- •Absolute neutrophil count ≥1500/mm³
- •Platelet count ≥75,000/mm³
- •Creatinine clearance ≥40ml/min
- •Total bilirubin ≤1.5x ULN. Higher levels are acceptable if these can be attributed to active haemolysis or ineffective erythropoiesis.
- •AST (SGOT) and ALT (SGPT) ≤2x ULN
- •Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to KPT-330 treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.
- •Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal.
- •For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
- •As the effects of selinexor on the developing human fetus at the recommended therapeutic dose are unknown, women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with selinexor. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women that are pregnant or breastfeeding are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
- •Patients must be able to understand and willing to sign a written informed consent document.
- •Patients must be able to adhere to the study visit schedule and other protocol requirements.
- •Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
排除标准
- •Patients who have had prior malignancies (other than T and NK/T-cell lymphomas) for ≤5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- •Patients who have had other anti-cancer therapy, including radiation or experimental drug or therapy, within 28 days of enrollment.
- •Patients with known HIV, active hepatitis B, active hepatitis C.
- •Patients with known central nervous system involvement by lymphoma.
- •Patients with known or suspected hypersensitivity to selinexor.
- •Inclusion of Women and Minorities:
- •Men and women of all ethnic groups are eligible for this study
研究组 & 干预措施
Selinexor and ICE Chemotherapy
Experimental
干预措施: Selinexor (Drug)
Selinexor and ICE Chemotherapy
Experimental
干预措施: ICE Chemotherapy (Drug)
结局指标
主要结局
Number of participants with treatment related dose limiting toxicity as assessed by NCI CTCAE v4.0
时间窗: The first 3 weeks of treatment
次要结局
- Overall survival(From the start of treatment to the date of death from any cause, up to 2 years)
- Overall response rate(From the start of treatment to the best overall response of Complete or Partial Response is achieved, up to 2 years)
- Progression-free survival(From the start of the treatment to the date of documentation of either disease progression or death, up to 2 years)
研究者
研究点 (1)
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