Back to resultsRelative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
Primary Purpose
Nausea, Vomiting, Chemotherapy
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Oral Aprepitant
Aprepitant
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring pediatrics, nausea, vomiting, chemotherapy, antiemetic
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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Bioavailability of the oral suspension relative to the capsule
Secondary Outcome Measures
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
Proportion of children with adverse effects attributable to aprepitant
Full Information
NCT ID
NCT01249001
First Posted
November 23, 2010
Last Updated
April 18, 2017
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01249001
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of eligible participants to enrol
Study Start Date
October 2010 (Actual)
Primary Completion Date
September 28, 2016 (Actual)
Study Completion Date
September 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Chemotherapy
Keywords
pediatrics, nausea, vomiting, chemotherapy, antiemetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
Subject will receive an oral suspension containing 125mg of Aprepitant
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
Subjects will receive a 125 mg Aprepitant capsule
Primary Outcome Measure Information:
Title
Bioavailability of the oral suspension relative to the capsule
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Severity of chemotherapy-induced nausea and vomiting (CINV)
Description
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
Title
Proportion of children with adverse effects attributable to aprepitant
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Dupuis, RPh, MScPhm, ACPR, FCSH
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
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