Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

Phase 2TerminatedNCT01249001

The Hospital for Sick Children4 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nausea Vomiting Chemotherapy

Interventions

Oral AprepitantDRUG

Subject will receive an oral suspension containing 125mg of Aprepitant

AprepitantDRUG

Subjects will receive a 125 mg Aprepitant capsule

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Bioavailability of the oral suspension relative to the capsule

Time frame: 6 weeks

Secondary Outcomes

Severity of chemotherapy-induced nausea and vomiting (CINV)

Subject will be asked to record episodes of nausea and vomiting that occur during and immediately following each chemotherapy cycle studied

Time frame: 6 weeks

Proportion of children with adverse effects attributable to aprepitant

Time frame: 6 weeks

Data from ClinicalTrials.gov

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