An Investigator Initiated, Open Label, Prospective Study To EvaluateEffectiveness of Fosaprepitant IV In Prevention Of Chemotherapy Induced Vomiting In PediatricPatients: Fosaped Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 1. Proportion of patients who achieved a complete response (defined as no vomiting, no use of rescue medication) during the 25–120 hours (delayed phase).
研究概览
简要总结
The study is An Investigator Initiated, Open Label, Prospective Study to evaluate effectiveness and safety of Fosaprepitant in Prevention of Chemotherapy Induced Vomiting in Pediatric Patients: FOSAPED Trial.
Eligible subjects who meet all the inclusion and exclusion criteria will be recruited after obtaining informed written consent from the parents. Oral assent will be obtained for children between the age of 7 and 12 years.
Patients randomized to the Fosaprepitant arm will receive Fosaprepitant 3 mg/kg (maximum 150 mg) as a short IV infusion in 100 ml normal saline over 30 minutes and Patients randomized to the placebo arm will receive 100 ml normal saline as a placebo over 30 minutes.Overall study duration for each subject is 6 days.
From the start of chemotherapy infusion on day 1 through the morning of day 6 (0–120 h), each patient/caretaker will complete a diary.
The diary will be checked daily by the investigator for patients admitted in the hospital, and entries by the parent/guardian will be confirmed telephonically by the investigator daily for patients discharged from the hospital. Diary will be collected back from the patient on Day 6. Complete response is defined as no vomiting and no need for rescue medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 1 to 12 years Patients with Histologically or cytological confirmed tumors Patient naïve to chemotherapy.
- •Scheduled to receive their first course of chemotherapy (HEC/MEC) for treatment of a solid malignant tumor.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Predicted life expectancy of at least 3 months Willing to provide written informed consent by parent or guardian and oral assent by patient.
排除标准
- •Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and
- •Bone marrow or stem-cell transplant.
- •Vomiting, retching, or more than mild nausea within 24 hours before day 1 Children with allergy to NK-1 antagonists or 5HT3 antagonists Children with active infection Children with congestive heart failure or known history of QT prolongation on electrocardiogram Abnormal blood parameter (absolute neutrophil count < 1000/mm3, platelet count < 100 000/mm3) Abnormal kidney function indicated by a serum creatinine more than the upper limit of normal (ULN) for age Abnormal liver function test indicated by serum aspartate aminotransferase and alanine aminotransferase five times the ULN for age and serum bilirubin 1.5 times the ULN for age Not willing to participate in the study or who have participated in any other clinical study in past 1 month.
结局指标
主要结局
1. Proportion of patients who achieved a complete response (defined as no vomiting, no use of rescue medication) during the 25–120 hours (delayed phase).
时间窗: 1. no vomiting, no use of rescue medication) during the 25–120 hours (delayed phase)
次要结局
- 1. Proportion of patients who achieved complete response during the acute (0–24 hours) and overall phases.(2. Any adverse effect seen or reported by patient/caretaker.)