Status:
TERMINATED
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief 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 ar...
Detailed Description
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. In a recent su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01249001
Start Date
October 1 2010
End Date
September 28 2016
Last Update
April 19 2017
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8