EUCTR2006-005515-10-SE进行中（未招募）不适用
A Multi-center, Open-label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient is 6 months to 17 years of age at the time of study entry.
- •2. Patient is scheduled to receive moderately or highly emetogenic chemotherapy for a documented malignancy as defined OR patient did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
- •3. Patient is expected to receive ondansetron as part of their antiemetic regimen.
- •4. Female patient who has begun menses has a negative urine pregnancy test prior to randomization.
- •5. Patients weight = 7.5 kg.
- •6. Patient has a preexisting functioning central or venous catheter prior to receiving aprepitant/fosaprepitant designated for pharmacokinetic sampling.
- •For Parts I and V only: a double lumen central venous catheter or a single lumen central venous catheter (for fosaprepitant administration) along with a peripheral venous catheter (for pharmacokinetic sampling) is required.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 82
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy.
- •2. Patient has ever participated in a study with aprepitant or fosaprepitant, is currently participating in a study with casopitant or has taken a non-approved (investigational) drug within the last 4 weeks.
- •Note: Patients on investigational studies with marketed chemotherapeutic agents are allowed to enroll if they fulfill all other entry criteria
- •3. Patient is allergic to aprepitant, fosaprepitant, ondansetron or any other 5 HT3 antagonist.
- •4. Patient has a symptomatic primary or metastatic CNS malignancy.
- •5. Patient must meet all satisfy all laboratory value criteria as stated in the protocol.
- •6. Patient has been treated with specified antiemetic agents within 48 hours prior to Study Day 1.
- •7. Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of their chemotherapy regimen.
- •Exceptions:
- •- Patients who are receiving chronic (>72 hours), daily steroid therapy can be enrolled provided the steroid dose is not >0.14 mg/kg up to 10 mg of prednisone daily or equivalent.
- •- Patients are allowed to receive a single dose of a corticosteroid within 3 days prior (but not on the day of study drug administration) provided it is < the equivalent of 20 mg of prednisone.
- •- Patients are allowed to receive corticosteroids administered for antiemetic prophylaxis starting on study Day 1.
- •8. Patient is taking, or has taken within 7 days of study drug administration the following CYP3A4 substrates:
- •- Terfenadine, cisapride, astemizole, pimozide, and amifostine
- •9. Patient is taking, or has taken within the 7 days of Treatment Day 1 the following CYP3A4 inhibitors:
- •- Clarithromycin, erythromycin, ketoconazole, itraconazole, fluconazole, telithromycin
- •10. Patient is taking, or has taken within 30 days of Study Day 1 the following CYP3A4 inducers:
- •- Barbiturates, rifampicin or rifabutin, phenytoin or carbamazepine, and St. Johns Wort
研究者
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