Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

• Status: Terminated
• Trial end date: 2016-09-28
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Aprepitant; Fosaprepitant

Criteria

Inclusion Criteria:

• 12-18 years of age;

• able to swallow whole capsules;

• weighing ≥40kg;

• AST, ALT no more than 3 times the upper limit of normal for age and bilirubin concentrations within normal limits;

• receiving 2 consecutive (within 8 weeks) eligible, though not necessarily identical, IV chemotherapy cycles;

• English speaking (nausea assessment tool (PeNAT30) has been validated only in English)

• cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional (to permit self-assessment of nausea severity).

Exclusion Criteria:

• receiving very cisplatin containing chemotherapy (aprepitant capsule administration to these patients is the current standard of care at Sick Kids)

• receiving chemotherapy within 5 days before,during or 5 days after either study cycle that is known or suspected to interact with aprepitant; that is, cyclophosphamide, doxorubicin, daunomycin, etoposide, irinotecan, ifosfamide, imatinib, paclitaxel, topotecan, vinorelbine, vinblastine and vincristine;

• receiving medication known to interact with aprepitant other than dexamethasone (see Appendix I for list of applicable agents and timeframe for exclusion);

• Pregnant or breastfeeding