A Study to Evaluate Safety and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Children Receiving Emetogenic Chemotherapy

• Conditions: Chemotherapy induced nausea and vomiting (CINV); MedDRA version: 16.1Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomitingSystem Organ Class: 100000004865; MedDRA version: 16.1Level: LLTClassification code 10056989Term: Nausea post chemotherapySystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2006-005515-10-SE
• Lead Sponsor: Merck Sharp & Dohme Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-12
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 82

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 = 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified