Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

This study has been terminated.
(Study terminated early prior to completing targeted enrollment of participants <6 months of age due to recruitment challenges.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00818259
First received: January 6, 2009
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: October 2, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chemotherapy-Induced Nausea and Vomiting
Interventions: Drug: Experimental: aprepitant
Drug: Experimental: fosaprepitant
Drug: Comparator: ondansetron
Drug: Ondansetron
Drug: Dexamethasone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 92 unique participants who were enrolled and randomized in Parts I (n=23), II (n=39), III (n=19), IV (n=5) and V (n=6), 91 took part in this study. One participant randomized in Part IIB was discontinued prior to treatment.

Reporting Groups
  Description
Part IA-fosaprepitant 115 mg/Aprepitant Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part IB-fosaprepitant 150 mg Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part IIA-aprepitant 80 mg Equiv. Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part IIB-aprepitant 125 mg Equiv. Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part III-ondansetron Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
Part IV-aprepitant Regimen Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
Part IV-Additional Enrollers Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
Part V-fosaprepitant Regimen Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part V-Additional Enrollers Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.

Participant Flow for 6 periods

Period 1:   Randomization
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part IV-Additional Enrollers     Part V-fosaprepitant Regimen     Part V-Additional Enrollers  
STARTED     12     11     19     20     19     0     5     0     6  
COMPLETED     12     11     19     20     19     0     5     0     6  
NOT COMPLETED     0     0     0     0     0     0     0     0     0  

Period 2:   Part I
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part IV-Additional Enrollers     Part V-fosaprepitant Regimen     Part V-Additional Enrollers  
STARTED     12 [1]   11 [1]   0     0     0     0     0     0     0  
COMPLETED     11     11     0     0     0     0     0     0     0  
NOT COMPLETED     1     0     0     0     0     0     0     0     0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0                 0                 0                 0  
[1] Newly enrolled participants

Period 3:   Part II
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part IV-Additional Enrollers     Part V-fosaprepitant Regimen     Part V-Additional Enrollers  
STARTED     0     0     19 [1]   20 [1]   0     0     0     0     0  
Treated     0     0     19     19     0     0     0     0     0  
COMPLETED     0     0     18     18     0     0     0     0     0  
NOT COMPLETED     0     0     1     2     0     0     0     0     0  
Physician Decision                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 0                 0                 0                 1                 0                 0                 0                 0                 0  
Not Treated                 0                 0                 0                 1                 0                 0                 0                 0                 0  
[1] Newly enrolled participants

Period 4:   Part III
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part IV-Additional Enrollers     Part V-fosaprepitant Regimen     Part V-Additional Enrollers  
STARTED     0     0     0     0     19 [1]   0     0     0     0  
COMPLETED     0     0     0     0     19     0     0     0     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0  
[1] Newly enrolled participants

Period 5:   Part IV
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part IV-Additional Enrollers     Part V-fosaprepitant Regimen     Part V-Additional Enrollers  
STARTED     0     0     0     0     0     15 [1]   5 [2]   0     0  
COMPLETED     0     0     0     0     0     14     5     0     0  
NOT COMPLETED     0     0     0     0     0     1     0     0     0  
Physician Decision                 0                 0                 0                 0                 0                 1                 0                 0                 0  
[1] Participants continuing from Part III
[2] Newly enrolled participants

Period 6:   Part V
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part IV-Additional Enrollers     Part V-fosaprepitant Regimen     Part V-Additional Enrollers  
STARTED     0     0     0     0     0     0     0     17 [1]   6 [2]
COMPLETED     0     0     0     0     0     0     0     16     6  
NOT COMPLETED     0     0     0     0     0     0     0     1     0  
Adverse Event                 0                 0                 0                 0                 0                 0                 0                 1                 0  
[1] Participants continuing from Part IV
[2] Newly enrolled participants



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For analysis purposes, baseline (BL) data are presented by study part groups. The BL analysis population includes all unique enrolled participants in Parts I, II, III, IV and V. Part III participants who entered Parts IV and V are only counted in Part III; Part IV participants who entered Part V are only counted in Part IV.

Reporting Groups
  Description
Part IA-fosaprepitant 115 mg/Aprepitant Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part IB-fosaprepitant 150 mg Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part IIA-aprepitant 80 mg Equiv. Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part IIB-aprepitant 125 mg Equiv. Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Part III-ondansetron Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
Part IV-aprepitant Regimen Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
Part V-fosaprepitant Regimen Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Total Total of all reporting groups

Baseline Measures
    Part IA-fosaprepitant 115 mg/Aprepitant     Part IB-fosaprepitant 150 mg     Part IIA-aprepitant 80 mg Equiv.     Part IIB-aprepitant 125 mg Equiv.     Part III-ondansetron     Part IV-aprepitant Regimen     Part V-fosaprepitant Regimen     Total  
Number of Participants  
[units: participants]
  12     11     19     20     19     5     6     92  
Age, Customized  
[units: Participants]
               
6 months to <2 years     0     0     5     6     6     1     1     19  
2 years to <6 years     0     0     8     8     6     0     3     25  
6 years to <12 years     0     0     6     6     7     4     2     25  
12 years to 17 years     12     11     0     0     0     0     0     23  
Gender  
[units: Participants]
               
Female     7     7     12     14     13     3     6     62  
Male     5     4     7     6     6     2     0     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Maximum Plasma Concentration (Cmax) for Aprepitant   [ Time Frame: Up to 72 hours post fosaprepitant/aprepitant dose ]

3.  Primary:   Time to Cmax (Tmax) for Aprepitant   [ Time Frame: Up to 72 hours post fosaprepitant/aprepitant dose ]

4.  Primary:   Apparent Terminal Half-life (t1/2) for Aprepitant   [ Time Frame: Up to 72 hours post fosaprepitant/aprepitant dose ]

5.  Primary:   Cmax for Fosaprepitant   [ Time Frame: Up to 72 hours post fosaprepitant dose ]

6.  Primary:   Tmax for Fosaprepitant   [ Time Frame: Up to 72 hours post fosaprepitant dose ]

7.  Primary:   Number of Participants Experiencing Adverse Events (AEs)   [ Time Frame: Up to 14 days after last dose of study drug (Up to 17 days) ]

8.  Primary:   Number of Participants Discontinuing Study Drug Due to an AE   [ Time Frame: Day 1 up to Day 3 ]

9.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00818259     History of Changes
Other Study ID Numbers: 0869-134, 2009_501
Study First Received: January 6, 2009
Results First Received: October 2, 2014
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration