Clinical trial NCT00080444: Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.

Detailed description: The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional, open-label, 28-day cycles.

Eligibility criteria: Inclusion Criteria:

* Cycle 1: Participant is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented malignancy. OR Participant did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
* Cycle 1: Participant has Karnofsky score ≥60
* Cycle 1: Participant has a predicted life expectancy of ≥3 months

Exclusion Criteria:

* Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy.

Primary outcomes:
measure: Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1)
timeFrame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
Secondary outcomes:
measure: Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1)
timeFrame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
measure: Percentage of Participants Who Experience Absence of Nausea (Cycle 1)
timeFrame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
measure: Percentage of Participants Who Experience Absence of Vomiting (Cycle 1)
timeFrame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
measure: Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10)
timeFrame: Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)
measure: Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycles 2-10)
timeFrame: Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)
measure: Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10)
timeFrame: Up to Day 4 of Cycles 2-10 (Up to 10 months)
measure: Percentage of Participants Who Experience Serious Adverse Events (Cycle 1)
timeFrame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
measure: Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1)
timeFrame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
measure: Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1)
timeFrame: Up to Day 4 of Cycle 1
measure: Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics
timeFrame: Up to 24 hours after first dose of aprepitant
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gore L, Chawla S, Petrilli A, Hemenway M, Schissel D, Chua V, Carides AD, Taylor A, Devandry S, Valentine J, Evans JK, Oxenius B; Adolescent Aprepitant in Cancer Study Group. Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer. 2009 Feb;52(2):242-7. doi: 10.1002/pbc.21811.