An Open Label, Multicenter, Dose Finding, Single Arm, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer Receiving Folotyn® (Pralatrexate)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis
研究概览
简要总结
To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.
详细描述
This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •At least 18 years of age
- •Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC) after at least one line of therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Histologically or cytologically confirmed Stage III B/IV NSCLC
- •Adequate hematological, hepatic, and renal function
- •Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days
排除标准
- •Active concurrent malignancy. If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years
- •Congestive heart failure
- •Uncontrolled hypertension
- •Known human immunodeficiency virus (HIV)-positive diagnosis
- •Previous exposure to Pralatrexate
- •Pregnant or breast-feeding women
- •Major surgery within 14 days of enrollment
- •Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
- •Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
研究组 & 干预措施
Cohort 1 - Fusilev - 20 doses
5 mg/m2 QID (6 hours apart) starting on Days 2 and 16 (24 hours after Folotyn dose) for a total of 20 doses in a 28-day cycle
Days 2 and 16: 4 doses/day
Days 3 and 17: 4 doses/day
Days 4 and 18: 2 doses/day
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Folotyn (Drug)
Cohort 1 - Fusilev - 20 doses
5 mg/m2 QID (6 hours apart) starting on Days 2 and 16 (24 hours after Folotyn dose) for a total of 20 doses in a 28-day cycle
Days 2 and 16: 4 doses/day
Days 3 and 17: 4 doses/day
Days 4 and 18: 2 doses/day
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Fusilev (Drug)
Cohort 2 - Fusilev - 12 doses
5 mg/m2 BID 8 hours apart on Days 2, 3, 4, 16, 17, and 18 for a total of 12 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Folotyn (Drug)
Cohort 2 - Fusilev - 12 doses
5 mg/m2 BID 8 hours apart on Days 2, 3, 4, 16, 17, and 18 for a total of 12 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Fusilev (Drug)
Cohort 3 - Fusilev - 8 doses
5 mg/m2 BID 8 hours apart on Days 2, 3, 16, and 17 for a total of 8 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Folotyn (Drug)
Cohort 3 - Fusilev - 8 doses
5 mg/m2 BID 8 hours apart on Days 2, 3, 16, and 17 for a total of 8 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Fusilev (Drug)
Cohort 4 - Fusilev - 4 doses
5 mg/m2 BID 8 hours apart on Days 2 and 16 for a total of 4 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Folotyn (Drug)
Cohort 4 - Fusilev - 4 doses
5 mg/m2 BID 8 hours apart on Days 2 and 16 for a total of 4 doses in a 28-day cycle.
Fusilev dose to start 24 hours after Folotyn dose.
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Fusilev (Drug)
Cohort 5 - Fusilev - 2 doses
5 mg/m2 once on Days 2 and 16 for a total of 2 doses in a 28-day cycle
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Folotyn (Drug)
Cohort 5 - Fusilev - 2 doses
5 mg/m2 once on Days 2 and 16 for a total of 2 doses in a 28-day cycle
Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle
干预措施: Fusilev (Drug)
结局指标
主要结局
Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis
时间窗: Up to 8 weeks
The study period will begin on the first day of Folotyn treatment (Day 1). Folotyn will be administered intravenously (IV) at a dose of 190 mg/m2 on Days 1 and 15 in a 28-day treatment cycle. Twenty-four hours after the Folotyn dose, Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned. Within a given cohort, Fusilev will be administered at the same dose and schedule after each Folotyn dose for the duration of the study.
次要结局
- Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis(Up to 8 weeks)
- Impact of Fusilev on the frequency of Oral Mucositis(Up to 8 weeks)
- Impact of Fusilev on number of Folotyn doses delivered(Up to 8 weeks)
- Impact of Fusilev on use of Analgesics for Oral Mucositis(Up to 8 weeks)