E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nauseas y vómitos inducidos por quimioterapia Chemotherapy induced nausea and vomiting (CINV) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056989 |
E.1.2 | Term | Nausea post chemotherapy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036899 |
E.1.2 | Term | Prophylaxis against chemotherapy induced vomiting |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Primera indicación en niños |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |