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NCT Number: NCT01362530

A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)

This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants. Those who complete this first cycle of treatment and meet certain eligibility criteria will have the option of continuing for 5 additional cycles of open-label aprepitant.

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Key information

Conditions

Chemotherapy Induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Cycle 1:

  • Is 6 months to 17 years of age at time of study entry
  • Is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of vomiting for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting
  • Is expected to receive ondansetron as part of their antiemetic regimen
  • If female and has begun menses, must has a negative urine pregnancy test prior to

randomization. A female who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication

  • If >10 years old, have a Karnofsky score ≥ 60; if ≤ 10 years have a Lansky Play Performance score ≥ 60
  • Have a predicted life expectancy of ≥ 3 months

Optional Cycles 2-6:

  • Participant has, in the opinion of the investigator, completed the preceding cycle of chemotherapy and related study procedures satisfactorily

Exclusion criteria

Cycle 1:

  • Has vomited in the 24 hours prior to Treatment Day 1
  • Is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy
  • Has received or will receive radiation therapy to the abdomen or pelvis within a week prior to Treatment Day 1 or during the course of the study
  • Is pregnant or breast feeding
  • Is allergic to aprepitant, ondansetron, or any other 5-hydroxytryptamine type-3 receptor (5-HT3) antagonist
  • Has a symptomatic primary or metastatic CNS malignancy causing nausea and/or vomiting
  • History of QT prolongation or taking other medicinal products that lead to QT prolongation
  • Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug to the participant
  • Has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam
  • Has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen
  • Is currently taking warfarin

Optional Cycles 2-6:

  • All exclusion criteria from Cycle 1 apply except for vomiting in the 24 hours prior to Treatment Day 1

Treatment and study plan

Aprepitant 125 mg

Drug

On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age

Other names: MK-0869, Emend®

Aprepitant 80 mg

Drug

On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age

Other names: MK-0869, Emend®

Aprepitant powder for suspension (PFS)

Drug

On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age

Other names: MK-0869, Emend®

ondansetron

Drug

Day 1: Administered according to product label for pediatric usage or local standard of care

Other names: Zofran™

Placebo for Aprepitant 125 mg

Drug

On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age

Placebo for Aprepitant 80 mg

Drug

On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age

Placebo for Aprepitant PFS

Drug

On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age

Emetogenic chemotherapy

Drug

Any moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used."

Primary outcomes

  1. Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1

    Time frame: 25 to 120 hours after the start of chemotherapy

    Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.

Secondary outcomes

  1. Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1

    Time frame: 0 to 24 hours after initiation of chemotherapy

    Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1.

  2. Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1

    Time frame: 0 to 120 hours after initiation of chemotherapy

    Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1.

  3. Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1

    Time frame: 0 to 120 hours after initiation of chemotherapy

    Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 30, 2011
Registry last updated
Sep 25, 2018

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.

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