Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Terminated

CT.gov ID

NCT01249001

Collaborator

(none)

Enrollment

Location

Arms

71.9

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting Chemotherapy	Drug: Oral Aprepitant Drug: Aprepitant	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Actual Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 28, 2016

Actual Study Completion Date :

Sep 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Oral Aprepitant Subject will receive an oral suspension containing 125mg of Aprepitant Other Names: Emend Drug: Aprepitant Subjects will receive a 125 mg Aprepitant capsule Other Names: Emend
Experimental: 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.	Drug: Oral Aprepitant Subject will receive an oral suspension containing 125mg of Aprepitant Other Names: Emend Drug: Aprepitant Subjects will receive a 125 mg Aprepitant capsule Other Names: Emend

Arm

Intervention/Treatment

Experimental: 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.

Drug: Oral Aprepitant

Subject will receive an oral suspension containing 125mg of Aprepitant

Other Names:

Emend

Drug: Aprepitant

Subjects will receive a 125 mg Aprepitant capsule

Other Names:

Emend

Experimental: 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.

Drug: Oral Aprepitant

Subject will receive an oral suspension containing 125mg of Aprepitant

Other Names:

Emend

Drug: Aprepitant

Subjects will receive a 125 mg Aprepitant capsule

Other Names:

Emend

Outcome Measures

Primary Outcome Measures

Bioavailability of the oral suspension relative to the capsule [6 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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