Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

NCT01249001 | Terminated Phase 2

• 1 other identifier: 1000019462
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting; Chemotherapy

Keywords

pediatrics; nausea; vomiting; chemotherapy; antiemetic

Outcome Measures

Primary Outcomes (1)

• Bioavailability of the oral suspension relative to the capsule

  6 weeks

Secondary Outcomes (2)

• Severity of chemotherapy-induced nausea and vomiting (CINV)

  6 weeks

• Proportion of children with adverse effects attributable to aprepitant

  6 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Aprepitant

Group 2

EXPERIMENTAL

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; Drug: Aprepitant

Interventions

Oral Aprepitant DRUG

Subject will receive an oral suspension containing 125mg of Aprepitant

Also known as: Emend

Group 1; Group 2

Aprepitant DRUG

Subjects will receive a 125 mg Aprepitant capsule

Also known as: Emend

Group 1; Group 2

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Pregnant or breastfeeding

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lee Dupuis, RPh, MScPhm, ACPR, FCSH

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Clinical Manager

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 25, 2010
• Study Start: October 1, 2010
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

CA (1)