Clinical trial NCT01249001: Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
Official title: Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nausea
Vomiting
Chemotherapy
Keywords: pediatrics
nausea
vomiting
chemotherapy
antiemetic
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 4
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bioavailability of the oral suspension relative to the capsule
timeFrame: 6 weeks
Secondary outcomes:
measure: Severity of chemotherapy-induced nausea and vomiting (CINV)
timeFrame: 6 weeks
measure: Proportion of children with adverse effects attributable to aprepitant
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Lee Dupuis, RPh, MScPhm, ACPR, FCSH
role: PRINCIPAL_INVESTIGATOR
References: