Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

NCT ID: NCT01249001

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-09-28

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.

Conditions

Nausea; Vomiting; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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 Type: EXPERIMENTAL

Oral Aprepitant

Intervention Type: DRUG

Subject will receive an oral suspension containing 125mg of Aprepitant

Aprepitant

Intervention Type: DRUG

Subjects will receive a 125 mg Aprepitant capsule

Group 2

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 Type: EXPERIMENTAL

Oral Aprepitant

Intervention Type: DRUG

Subject will receive an oral suspension containing 125mg of Aprepitant

Aprepitant

Intervention Type: DRUG

Subjects will receive a 125 mg Aprepitant capsule

Interventions

Oral Aprepitant

Subject will receive an oral suspension containing 125mg of Aprepitant

Intervention Type: DRUG

Aprepitant

Subjects will receive a 125 mg Aprepitant capsule

Intervention Type: DRUG

Other Intervention Names

Emend; Emend

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lee Dupuis

Pharmacy Clinical Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee Dupuis, RPh, MScPhm, ACPR, FCSH

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000019462

Identifier Type: -

Identifier Source: org_study_id