An Investigator Initiated, Open Label, Prospective Study To EvaluateEffectiveness of Fosaprepitant IV In Prevention Of Chemotherapy Induced Vomiting In PediatricPatients: Fosaped Trial. - FOSAPED

Hemato Oncology Clinic0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients aged between 1 to 12 years
•Patients with Histologically or cytological confirmed tumors
•Patient naÃ¯ve 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.

•Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5.
•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.

发起方

Hemato Oncology Clinic