Trial record 2 of 439 for:    Experience Corps

Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondandsetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02519842
First received: August 7, 2015
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517) plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s) associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s) not previously tolerated due to vomiting. The primary hypothesis is that a single dose of fosaprepitant in combination with ondansetron provides superior control of CINV compared to ondansetron alone as measured by the percentage of participants with a Complete Response (no vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120 hours) following initiation of emetogneic chemotherapy in Cycle 1.

Condition Intervention Phase
Chemotherapy-induced Nausea and Vomiting
Drug: Fosaprepitant
Drug: Placebo for fosaprepitant
Drug: Ondansetron
Drug: Dexamethasone
Drug: 5-HT3 antagonist
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0517/Fosaprepitant and Ondansetron Versus Ondansetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Subjects Receiving Emetogenic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants Who Experience a Complete Response During the Delayed Phase (>24 to 120 hours post initiation of chemotherapy) in Cycle 1 [ Time Frame: >24 to 120 hours post initiation of chemotherapy ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience One or More Adverse Events [ Time Frame: Up to 6.5 months (Up to 2 weeks after last dose of study drug) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 6 months (Up to last dose of study drug) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants Who Experience a Complete Response During the Acute Phase (0 to 24 hours post initiation of chemotherapy) in Cycle 1 [ Time Frame: 0 to 24 hours post initiation of chemotherapy ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience a Complete Response During the Overall Phase (0 to 120 hours post initiation of chemotherapy) in Cycle 1 [ Time Frame: 0 to 120 hours post initiation of chemotherapy ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience No Vomiting, Regardless of Rescue Medication Use, During the Overall Phase (0 to 120 hours post initiation of chemotherapy) in Cycle 1 [ Time Frame: 0 to 120 hours post initiation of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosaprepitant Regimen
Cycle 1: Participants receive a single dose of fosaprepitant 150 mg or age-based adjustment, administered intravenously (IV) on Day 1 plus ondansetron IV on Day 1 and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may also receive dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Cycles 2-6: Participants receive a single dose of fosaprepitant 150 mg or age-based adjustment IV on Day 1 plus 5-HT3 antagonist on Day 1 and per product label or standard of care. Participants may also receive dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
Drug: Fosaprepitant
Other Name: EMEND®
Drug: Ondansetron Drug: Dexamethasone Drug: 5-HT3 antagonist
Placebo Comparator: Control Regimen
Cycle 1: Participants receive a single dose of placebo for fosaprepitant IV on Day 1 plus ondansetron IV on Day 1 and at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Participants may also receive dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy. Cycles 2-6: Participants receive a single dose of fosaprepitant 150 mg or age-based adjustment IV on Day 1 plus plus 5-HT3 antagonist on Day 1 and per product label or standard of care. Participants may also receive dexamethasone IV at investigator's discretion on day(s) of chemotherapy and up to 24 hours after chemotherapy.
Drug: Placebo for fosaprepitant Drug: Ondansetron Drug: Dexamethasone Drug: 5-HT3 antagonist

Detailed Description:
In Cycle 1, participants will receive double-blind study drug (fosaprepitant plus ondansetron with or without dexamethasone OR ondansetron with or without dexamethasone). Upon completion of Cycle 1, participants may have the option to continue for up to 5 additional open-label cycles, receiving fosaprepitant plus ondansetron with or without dexamethasone.
  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 0 (at least 37 weeks gestation) to 17 years of age at time of randomization
  • Have a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age)
  • Have a predicted life expectancy ≥3 months
  • Be receiving chemotherapeutic agent(s) associated with moderate or high risk of emetogenicity, or a chemotherapy regimen not previously tolerated due to vomiting
  • Have a preexisting functional central venous catheter available for study drug administration
  • Is male OR is female who is not of reproductive potential OR is female who is of reproductive potential and agrees to avoid becoming pregnant in the 28 days prior to receiving study drug, while receiving study drug and for at least 30 days after last dose of study drug.

Exclusion Criteria:

  • Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1
  • Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study)
  • Will be receiving stem cell rescue therapy in conjunction with study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant/placebo for fosaprepitant
  • Has received or will receive total body irradiation of radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy)
  • Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam
  • Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen
  • Is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-HT3 antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine (this is not an exhaustive list)
  • Is or has an immediate family member who is investigational site or sponsor staff directly involved with this study
  • Is currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence
  • Is mentally incapacitated or has a significant emotional or psychiatric disorder
  • Is pregnant or breast feeding
  • Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3 antagonist
  • Has a known history of QT prolongation or is taking any mediation that is known to lead to QT prolongation
  • Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy
  • Has ever participated in a previous study of aprepitant or fosaprepitant or has taken an investigational drug with the last 4 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02519842

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 24 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02519842     History of Changes
Other Study ID Numbers: 0517-044  2014-001783-34 
Study First Received: August 7, 2015
Last Updated: July 28, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Fosaprepitant
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Serotonin 5-HT3 Receptor Antagonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on July 28, 2016