Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

The Hospital for Sick Children

Status and phase: Terminated; Phase 2

Conditions: Vomiting; Nausea; Chemotherapy

Treatments: Drug: Oral Aprepitant; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT01249001

1000019462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: Aprepitant

Drug: Oral Aprepitant

Group 2

Experimental group

Description:

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.

Treatment:

Drug: Aprepitant

Drug: Oral Aprepitant