Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01362530
First received: May 26, 2011
Last updated: August 25, 2014
Last verified: August 2014

May 26, 2011
August 25, 2014
September 2011
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Percentage of Participants with Complete Response [ Time Frame: Up to 120 hours after the start of chemotherapy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01362530 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1 [ Time Frame: 0 to 24 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1 [ Time Frame: 0 to 120 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1 [ Time Frame: 0 to 120 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Chemotherapy Induced Nausea and Vomiting
  • 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™
  • 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
  • Drug: Emetogenic chemotherapy
    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."
  • Experimental: Aprepitant Regimen

    Cycle 1:

    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).

    Optional Cycles 2-6:

    Open-label aprepitant administered in the same manner as in Cycle 1.

    Interventions:
    • Drug: Aprepitant 125 mg
    • Drug: Aprepitant 80 mg
    • Drug: Aprepitant powder for suspension (PFS)
    • Drug: Ondansetron
    • Drug: Emetogenic chemotherapy
  • Placebo Comparator: Control Regimen
    Cycle 1: 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). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
    Interventions:
    • Drug: Ondansetron
    • Drug: Placebo for Aprepitant 125 mg
    • Drug: Placebo for Aprepitant 80 mg
    • Drug: Placebo for Aprepitant PFS
    • Drug: Emetogenic chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
August 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
6 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01362530
0869-208
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP