Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005372

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005372
  •   2013/10/17
  •   2012/09/28
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2012-002340-24 
  •   NCT01697579  (ClinicalTrials.gov)
  •   0517-029  (Merck)
  •   2012-002340-24 
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Health Condition or Problem studied

  •   Chemotherapy-induced Nausea and Vomiting
  •   R11 -  Nausea and vomiting
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Interventions/Observational Groups

  •   Drug: Fosaprepitant 150 mg
  •   Drug: Fosaprepitant 60 mg
  •   Drug: Fosaprepitant 20 mg
  •   Drug: Placebo Fosaprepitant
  •   Drug: Ondansetron
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Aprepitant Area Under the Curve (AUC) from 0 to ∞ hours (0-∞); time frame: Up to 25 hours postdose
- Aprepitant Maximum Concentration (Cmax); time frame: Up to 25 hours postdose
- Time to Aprepitant Cmax (Tmax); time frame: Up to 25 hours postdose
- Aprepitant Terminal Phase Half-Life (t1/2); time frame: Up to 25 hours postdose
- Aprepitant Apparent Total Body Clearance (CL/F); time frame: Up to 25 hours postdose
- Percentage of Participants Who Experience At Least One Adverse Event; time frame: Up to 14 days postdose

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Secondary Outcome

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Austria
  •   Canada
  •   Chile
  •   Colombia
  •   Estonia
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Lithuania
  •   Portugal
  •   Romania
  •   South Africa
  •   Spain
  •   Switzerland
  •   Taiwan, Province of China
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/12/31
  •   256
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   17   Years
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Additional 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)

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Merck
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    •   [---]*
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    • Toll Free Number 
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    •   1-888-577-8839
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    • Toll Free Number 
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    start of 1:1-Block address contact public-contact
    •   1-888-577-8839
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.