NCT03960151撤回2 期
Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.
Costantine Albany0 个研究点开始时间: 2018年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Complete Response Rate
研究概览
简要总结
Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- •Age ≥ 15 years at the time of consent.
- •Must be able to take oral medications (swallow pills)
- •ECOG Performance Status of 0-2 within 14 days prior to registration.
- •Histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen.
- •Patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy.
- •No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.
- •Prior cancer treatments are not allowed. Patients have to be chemotherapy naïve.
- •Absolute Neutrophil Count (ANC) ≥ 1 K/mm3
- •Hemoglobin (Hgb) ≥ 10 g/dL
- •Platelets (Plt) ≥ 100 K/mm3
- •Creatinine ≤ 2 mg/dL
- •Bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- •Alanine aminotransferase (ALT) ≤ 2.5 × ULN
- •No concurrent use of thioridazine or pimozide. No use of agents expected to induce the metabolism of rolapitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and Barbiturates.
- •As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
- •Patients and their partners must agree to use a highly effective method of birth control from the signing of the informed consent form until 90 days following the last dose of rolapitant.
排除标准
- •Any untreated central nervous system (CNS) metastases.
- •Treatment with any investigational drug within 30 days prior to registration.
- •Concurrent participation in a clinical trial which involves another investigational agent.
研究组 & 干预措施
Rolapitant
Experimental
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
干预措施: Rolapitant (Drug)
Rolapitant
Experimental
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
干预措施: Palonosetron (Drug)
Rolapitant
Experimental
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
干预措施: Olanzapine (Drug)
Rolapitant
Experimental
Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 8 Days
Determine the complete response (CR) rate defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 8
次要结局
- Complete Response Rate: Acute Phase(5 Days)
- Complete Response Rate: Delayed Phase(2 Days)
- Duration of Vomiting or retching(8 Days)
- Use of rescue medications(8 Days)
- Frequency, intensity, and duration of nausea(8 Days)
- Assess adverse events of regimen using CTCAE v4.(8 Days)
- Frequency of vomiting or retching.(8 Days)
- Rate of no nausea(8 Days)
- Intensity of Vomiting or retching.(8 Days)
研究者
Costantine Albany
Sponsor Investigator
Hoosier Cancer Research Network
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