Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 11
Updated:4/29/2016
Start Date:December 2012
End Date:January 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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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

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 (changed to birth to <12 years of age in
Amendment 04). Fosaprepitant is a prodrug to aprepitant. All participants who complete the
randomized Cycle 1 may elect to receive open-label fosaprepitant during optional Cycles 2-6.

As a result of Protocol Amendment 04, only one dose equivalent of open-label fosaprepitant
(5 mg/kg for participants <12 years to <=4 months of age, 2.5 mg/kg for participants <4
months to 1 month of age and 1.25 mg/kg for participants <1 month to 0 months of age) will
be evaluated in children aged birth to <12 years to allow for further pharmacokinetic,
pharmacodynamic, safety and tolerability assessments of fosaprepitant in participants from
birth to <12 years of age.

Inclusion Criteria:

- Is 0 months (at least 37 weeks gestation) to <18 years of age (Amendment 04: Changed
age eligibility criterion to: birth to <12 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 (Cycle 1); Expected to
receive a 5-HT3 antagonist as part of antiemetic regimen (Cycles 2-6)

- 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 (Cycle 1)

- 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-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
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