Nauseas y vómitos inducidos por quimioterapia Chemotherapy induced nausea and vomiting (CINV) MedDRA version: 9.1 Level: LLT Classification code 10056989 Term: Nausea post chemotherapy MedDRA version: 9.1 Level: LLT Classification code 10036899 Term: Prophylaxis against chemotherapy induced vomiting
Conditions
Interventions
Product Name: Aprepitant
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Aprepitant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Trade
Sponsors
Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 >= 6 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: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1 To estimate aprepitant plasma concentration profiles and pharmacokinetic parameters (AUC0-24, Cmax, Tmax, and C24 hr, on day 2 and day 3) obtained in patients 6 months to < 2- years, 2 to < 6 years, and 6 to < 12 years of age receiving moderately or highly emetogenic chemotherapy or a chemotherapy regimen not previously tolerated due to nausea and/or vomiting administered 3 day oral aprepitant with or without fosaprepitant. Refer to protocol for additional main objectives.;Secondary Objective: Exploratory Objectives: 1. To explore the efficacy of oral aprepitant administered as a single and three-day dose in addition to the 5HT3 antagonist, ondansetron in the control of CINV in patients 6 months to < 2- years, 2 to < 6 years, and 6 to < 12 years. 2. To explore the efficacy of Day 1 intravenous fosaprepitant with Day 2 and 3 oral aprepitant in addition to the 5HT3 antagonist, ondansetron in the control of CINV in patients 6 months to < 2 years, 2 to < 6 years, 6 to < 12 years, and 12 to 17 years.;Primary end point(s): Pharmacokinetic Endpoint: Aprepitant plasma pharmacokinetic (PK) profile (AUC0-24, Cmax, Tmax, and C24 hr) of the administered dose of either fosaprepitant or aprepitant on Day 1 from pediatric patients aged 6 months to 17 years will be determined. In addition, for Parts I, IV, and V, aprepitant plasma PK will be assessed 24 hr post administration of aprepitant on Day 2 and Day 3. Safety Endpoint: Drug-related, serious, and serious drug-related adverse experience(s) during fosaprepitant and/or aprepitant therapy plus 14 days post therapy or drug-related adverse experience(s) leading to discontinuation of fosaprepitant or aprepitant therapy. | — |
Countries
France, Germany, Hungary, Poland, Spain, Sweden
Outcome results
None listed