Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)

Merck Sharp & Dohme LLC50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Vomiting

Interventions

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1)

Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)

Secondary Outcomes

Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1)

Time frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1

Percentage of Participants Who Experience Absence of Nausea (Cycle 1)

Time frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1

Percentage of Participants Who Experience Absence of Vomiting (Cycle 1)

Time frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1

Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10)

Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)

Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycles 2-10)

Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)

Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10)

Time frame: Up to Day 4 of Cycles 2-10 (Up to 10 months)

Percentage of Participants Who Experience Serious Adverse Events (Cycle 1)

Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)

Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1)

Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)

Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1)

Time frame: Up to Day 4 of Cycle 1

Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics

Time frame: Up to 24 hours after first dose of aprepitant