Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Phase 2

Terminated

• Conditions: Nausea; Vomiting; Chemotherapy
• Interventions: Drug: Oral Aprepitant; Drug: Aprepitant

• Registration Number: NCT01249001
• Lead Sponsor: The Hospital for Sick Children

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 are likely to cause vomiting.

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 survey, parents of children receiving chemotherapy in Ontario centres identified nausea as the fourth most prevalent and bothersome treatment-related symptom experienced by their children. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to children.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2016-09-28
• Study Completion: 2016-09-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Aprepitant	This group will receive oral aprepitant on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the capsule on the first day of the second study cycle of chemotherapy.
Group 1	Oral Aprepitant	This group will receive oral aprepitant on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the capsule on the first day of the second study cycle of chemotherapy.
Group 2	Oral Aprepitant	This group will receive an aprepitant capsule on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the oral aprepitant on the first day of the second study cycle of chemotherapy.
Group 2	Aprepitant	This group will receive an aprepitant capsule on the first day of the first study cycle of chemotherapy. They will then cross-over to receive the oral aprepitant on the first day of the second study cycle of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Bioavailability of the oral suspension relative to the capsule	6 weeks

Secondary Outcome Measures

Name	Time	Method
Severity of chemotherapy-induced nausea and vomiting (CINV)	6 weeks	Subject will be asked to record episodes of nausea and vomiting that occur during and immediately following each chemotherapy cycle studied
Proportion of children with adverse effects attributable to aprepitant	6 weeks

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada