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 AM3) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chemotherapy Induced Nausea and Vomiting	Drug: Aprepitant 125 mg Drug: Aprepitant 80 mg Drug: Aprepitant powder for suspension (PFS) Drug: Ondansetron Drug: Placebo for Aprepitant 125 mg Drug: Placebo for Aprepitant 80 mg Drug: Placebo for Aprepitant PFS	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant Fosaprepitant Fosaprepitant dimeglumine

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of Participants with a Complete Response (Intent-to-Treat Population) [ Time Frame: 25 to 120 hours after the start of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Participants with a Complete Response (Intent-to-Treat Population) [ Time Frame: Up to 24 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
Percentage of Participants with a Complete Response (Intent-to-Treat Population) [ Time Frame: Up to 120 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
Percentage of Participants with No Vomiting (Intent-to-Treat Population) [ Time Frame: Up to 120 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2011
Estimated Study Completion Date:	August 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aprepitant Regimen Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).	Drug: Aprepitant 125 mg 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 Name: MK-0869, Emend® Drug: Aprepitant 80 mg On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age Other Name: MK-0869, Emend® Drug: Aprepitant powder for suspension (PFS) 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 Name: MK-0869, Emend® Drug: Ondansetron Day 1: Administered according to product label for pediatric usage or local standard of care Other Name: Zofran™
Placebo Comparator: Control Regimen Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).	Drug: Ondansetron Day 1: Administered according to product label for pediatric usage or local standard of care Other Name: Zofran™ Drug: Placebo for Aprepitant 125 mg On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age Drug: Placebo for Aprepitant 80 mg On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age Drug: Placebo for Aprepitant PFS 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

Arms

Assigned Interventions

Experimental: Aprepitant Regimen

Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).

Drug: Aprepitant 125 mg

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 Name: MK-0869, Emend®

Drug: Aprepitant 80 mg

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

Other Name: MK-0869, Emend®

Drug: Aprepitant powder for suspension (PFS)

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 Name: MK-0869, Emend®

Drug: Ondansetron

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

Other Name: Zofran™

Placebo Comparator: Control Regimen

Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).

Drug: Ondansetron

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

Other Name: Zofran™

Drug: Placebo for Aprepitant 125 mg

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

Drug: Placebo for Aprepitant 80 mg

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

Drug: Placebo for Aprepitant PFS

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

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01362530 History of Changes
Other Study ID Numbers:	0869-208
Study First Received:	May 26, 2011
Last Updated:	April 2, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 16, 2013