NCT06114004招募中2 期
Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas11 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年9月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 11
- 主要终点
- progression-free survival rate (PFSR)
研究概览
简要总结
Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.
Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.
详细描述
Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.
Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.
In the Phase I part safety and toxicity of the combination will be assessed using a 3+3 design. The recommended dose for the Phase II will be determined.
In the Phase II part there will be 2 different cohorts:
Cohort 1: Leiomyosarcoma (LMS) Cohort 2: Malignant peripheral nerve sheath tumor (MPNST)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
- •Age: 18-80 years.
- •Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded tumor tissue block must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational products.
- •Metastatic/advanced disease in progression in the last 6 months.
- •Patients have previously received at least one previous line of systemic therapy.
- •Measurable disease according to RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •Adequate hepatic, renal, cardiac, and hematologic function.
- •Laboratory tests as follows:
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan.
- •Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
排除标准
- •Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).
- •Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
- •Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 5 years prior to randomization. Cancer treated with curative intent for >5 years previously and without evidence of recurrence will be allowed.
- •Prior selinexor or another XPO1 inhibitor treatment.
- •Administration of a previous gemcitabine-containing treatment.
- •Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- •Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- •Pregnant or breastfeeding females.
- •Body surface area (BSA) <1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.
- •Life expectancy of less than 3 months.
- •Major surgery within 4 weeks prior to C1D
- •Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.
- •Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care).
- •Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- •Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
- •Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
研究组 & 干预措施
gemcitabine + selinexor:
Experimental
Selinexor will be given at 60 mg once per week orally days 1, 8 and 15 every 21 days
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days
干预措施: Selinexor 20 MG (Drug)
gemcitabine + selinexor:
Experimental
Selinexor will be given at 60 mg once per week orally days 1, 8 and 15 every 21 days
Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days
干预措施: Gemcitabine (Drug)
结局指标
主要结局
progression-free survival rate (PFSR)
时间窗: 6 months
To evaluate the efficacy of the selinexor plus gemcitabine combination as measured by the progression-free survival rate (PFSR) at 6 months in patients with selected advanced soft-tissue sarcomas.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(6 months)
- Overall survival (OS)(6 months)
- Overall response rate (ORR) according to RECIST 1.1(6 months)
- Evaluate the efficacy according to Choi response(6 months)
- Patients's quality of life (QoL)(6 months)
研究者
研究点 (11)
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