Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003768

Trial Description

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Title

A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving 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

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for
the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0
months to 17 years of age.

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Brief Summary in Scientific Language

Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after
intravenous administration; the pharmacological effect of fosaprepitant is attributed to
aprepitant. The birth to one year old cohort will be initiated in Parts III and IV upon
completion of Part II (Steps A and B) in participants <6 months of age.

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Organizational Data

  •   DRKS00003768
  •   2012/11/16
  •   2009/01/06
  •   no
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Secondary IDs

  •   NCT00818259  (ClinicalTrials.gov)
  •   0869-134  (Merck Sharp & Dohme Corp.)
  •   2009_501 
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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: Experimental: aprepitant
  •   Drug: Experimental: fosaprepitant
  •   Drug: Comparator: ondansetron
  •   Drug: Ondansetron
  •   Drug: Dexamethasone
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
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Primary Outcome

- Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant; time frame: Up to 24 hours post fosaprepitant/aprepitant dose; AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.
- Maximum Plasma Concentration (Cmax) for Aprepitant; time frame: Up to 72 hours post fosaprepitant/aprepitant dose; Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
- Time to Cmax (Tmax) for Aprepitant; time frame: Up to 72 hours post fosaprepitant/aprepitant dose; Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
- Apparent Terminal Half-life (t1/2) for Aprepitant; time frame: Up to 72 hours post fosaprepitant/aprepitant dose; t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
- Cmax for Fosaprepitant; time frame: Up to 72 hours post fosaprepitant dose; Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
- Tmax for Fosaprepitant; time frame: Up to 72 hours post fosaprepitant dose; Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
- Number of Participants Experiencing Adverse Events (AEs); time frame: Up to 14 days after last dose of study drug (Up to 17 days); An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.
- Number of Participants Discontinuing Study Drug Due to an AE; time frame: Day 1 up to Day 3; An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.

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Secondary Outcome

- Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age; time frame: Up to 24 hours post dexamethasone dose; Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.

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Countries of Recruitment

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Locations of Recruitment

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Recruitment

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  •   2009/02/27
  •   58
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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

- Is scheduled to receive moderately to highly nausea-inducing chemotherapy or
participant did not tolerate a previous chemotherapy regimen that is planned to be
repeated

- Is expected to receive ondansetron

- Female participants who have begun menstruating must have a negative pregnancy test

- Weighs ≥3.0 kg if <6 months of age, ≥6.0 kg if >6 months of age, and ≥7.5 kg if > 2
years of age

- Has a pre-existing venous catheter

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Exclusion Criteria

- Uses any illicit drugs or abuses alcohol

- Is pregnant or breast feeding

- Has a symptomatic central nervous system (CNS) tumor

- Has an infection or other uncontrolled disease other than cancer

- Has known history of heart QT wave prolongation

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Addresses

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    • Merck Sharp & Dohme Corp.
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    • Merck Sharp & Dohme Corp.
    • Medical Monitor 
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    • Merck Sharp & Dohme Corp.
    • Medical Monitor 
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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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Status

  •   Recruiting stopped after recruiting started
  •   2014/01/01
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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 .
  •   4
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.