Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children Under 18 Years of Age (MK-0517-029 AM3)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01697579
First received: September 28, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to 17 years of age. Fosaprepitant is a prodrug to aprepitant.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy-induced Nausea and Vomiting |
Drug: Fosaprepitant 150 mg Drug: Fosaprepitant 60 mg Drug: Fosaprepitant 20 mg Drug: Placebo Fosaprepitant Drug: Ondansetron |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Emetogenic Chemotherapy |
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:
- Aprepitant Area Under the Curve (AUC) from 0 to ∞ hours (0-∞) [ Time Frame: Up to 25 hours postdose ] [ Designated as safety issue: No ]
- Aprepitant Maximum Concentration (Cmax) [ Time Frame: Up to 25 hours postdose ] [ Designated as safety issue: No ]
- Time to Aprepitant Cmax (Tmax) [ Time Frame: Up to 25 hours postdose ] [ Designated as safety issue: No ]
- Aprepitant Terminal Phase Half-Life (t1/2) [ Time Frame: Up to 25 hours postdose ] [ Designated as safety issue: No ]
- Aprepitant Apparent Total Body Clearance (CL/F) [ Time Frame: Up to 25 hours postdose ] [ Designated as safety issue: No ]
- Percentage of Participants Who Experience At Least One Adverse Event [ Time Frame: Up to 14 days postdose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 256 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fosaprepitant 150 mg
Fosaprepitant 150 mg (or weight-adjusted equivalent for children <12 years of age), administered intravenously (IV) plus ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), administered IV
|
Drug: Fosaprepitant 150 mg
Administered IV as a single dose
Other Names:
Drug: Ondansetron
Administered IV
Other Names:
|
|
Experimental: Fosaprepitant 60 mg
Fosaprepitant 60 mg (or weight-adjusted equivalent for children <12 years of age), administered IV plus ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), administered IV
|
Drug: Fosaprepitant 60 mg
Administered IV as a single dose
Other Names:
Drug: Ondansetron
Administered IV
Other Names:
|
|
Experimental: Fosaprepitant 20 mg
Fosaprepitant 20 mg (or weight-adjusted equivalent for children <12 years of age), administered IV plus ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), administered IV
|
Drug: Fosaprepitant 20 mg
Administered IV as a single dose
Other Names:
Drug: Ondansetron
Administered IV
Other Names:
|
|
Active Comparator: Ondansetron
Matching Placebo to fosaprepitant, administered IV plus ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), administered IV
|
Drug: Placebo Fosaprepitant
Administered IV as a single dose
Drug: Ondansetron
Administered IV
Other Names:
|
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is 0 (at least 37 weeks gestation) to 17 years of age
- Scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting
- Expected to receive ondansetron as part of antiemetic regimen
- If female and has begun menstruating, must have a negative pregnancy test prior to study participation and agree to remain abstinent or use a barrier form of contraception
- Predicted life expectancy of >=3 months
- Pre-existing functioning central venous catheter
- Weight >=3rd percentile for age and gender (and >=3.0 kg)
Exclusion Criteria:
- Vomited in the 24 hours prior study drug administration
- Current user of any illicit drugs (including marijuana) or current evidence of alcohol abuse
- Scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy
- Received or will receive radiation therapy to the abdomen or pelvis in the week prior to study drug administration and/or during the course of the study
- Pregnant or breast feeding
- Allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-hydroxytryptamine type-3 receptor (5-HT3) antagonist
- Has a symptomatic central nervous system (CNS) tumor causing nausea and/or vomiting
- Has an active infection, congestive heart failure, slow heart rate, or other uncontrolled disease other than cancer
- Mentally incapacitated or has a significant emotional or psychiatric disorder
- Known history of QT prolongation or is taking any medication known to lead to QT prolongation
- Taking other excluded medications
- Participated in any previous study of aprepitant or fosaprepitant, or taken an investigational drug within 4 weeks prior to study participation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697579
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| United States, New York | |
| Call for Information (Investigational Site 0121) | Recruiting |
| New York, New York, United States, 10032 | |
| United States, Texas | |
| Call for Information (Investigational Site 0005) | Recruiting |
| Austin, Texas, United States, 78723 | |
| Austria | |
| MSD Osterreich GmbH | Recruiting |
| Vienna, Austria | |
| Contact: Karl Boegl 43 126044130 | |
| Estonia | |
| Merck Sharp & Dohme OU | Recruiting |
| Tallinn, Estonia | |
| Contact: Andrius Bacevicius 370 52780243 | |
| Germany | |
| Merck Sharp & Dohme GmbH | Recruiting |
| Haar, Germany | |
| Contact: Kristian Lobner 49 89 4561 1102 | |
| Greece | |
| Vianex, S.A. / MSD | Recruiting |
| Alimos, Greece | |
| Contact: Platon Peristaris 30 2109897322 | |
| Hungary | |
| MSD Pharma Hungary Kft. | Recruiting |
| Budapest, Hungary | |
| Contact: Simona Martinkova 36 1 457 8522 | |
| Portugal | |
| Merck Sharp & Dohme Lda. | Recruiting |
| Paco D arcos, Portugal | |
| Contact: Ana Maria Nogueira 351-21-4465890 | |
| Spain | |
| Merck Sharp and Dohme de Espana S.A. | Recruiting |
| Madrid, Spain | |
| Contact: Cesar Sanz Rodriguez 34 913210600 | |
| Switzerland | |
| MSD International GmbH | Recruiting |
| Lucerne 6, Switzerland | |
| Contact: Christiane Andrea Belly 41 58 618 15 99 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01697579 History of Changes |
| Other Study ID Numbers: | 0517-029, 2012-002340-24 |
| Study First Received: | September 28, 2012 |
| Last Updated: | April 19, 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 21, 2013