Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents

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.

Study Overview

• Status: Terminated
• Conditions: Nausea; Vomiting; Chemotherapy
• Intervention / Treatment: Drug: Oral Aprepitant; Drug: Aprepitant

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioavailability of the oral suspension relative to the capsule	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks
Proportion of children with adverse effects attributable to aprepitant		6 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Lee Dupuis, RPh, MScPhm, ACPR, FCSH, The Hospital for Sick Children, Toronto Canada

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): September 28, 2016
• Study Completion (Actual): September 28, 2016

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (Estimate): November 25, 2010

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: pediatrics; chemotherapy; nausea; vomiting; antiemetic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant; Fosaprepitant
• Other Study ID Numbers: 1000019462