Skip to main content
OpenTrials
Completed

NCT Number: NCT00080444

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant

Drug

aprepitant capsules

ondansetron

Drug

ondansetron IV preparation

Dexamethasone

Drug

dexamethasone tablets

placebo to aprepitant

Drug

Matching placebo to aprepitant capsules

placebo to dexamethasone

Drug

Matching placebo to dexamethasone tablets

Rescue medication

Drug

Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives.

Primary outcomes

  1. 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

  1. 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

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

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

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

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

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

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

    Time frame: Up to Day 4 of Cycle 1

  10. Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Apr 2, 2004
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.