Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy

This study has been terminated.
(Drug contract timelines and inadequate enrollment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01031953
First received: December 13, 2009
Last updated: February 3, 2014
Last verified: February 2014
Results First Received: October 10, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breakthrough Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: fosaprepitant dimeglumine
Drug: systemic chemotherapy
Other: survey administration
Procedure: quality-of-life assessment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from August 2008 until January 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 34 participants who signed the informed consent for this study but of these, only 11 received the study treatment. The other 23 were screen failures.

Reporting Groups
  Description
Fosaprepitant A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy

Participant Flow:   Overall Study
    Fosaprepitant  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Fosaprepitant No text entered.

Baseline Measures
    Fosaprepitant  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 12  
Gender  
[units: participants]
 
Female     5  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale   [ Time Frame: Baseline to 2 hours after study drug administered. ]

2.  Secondary:   Improvement in Nausea Score From Baseline to 12 Hours   [ Time Frame: Baseline to 12 hours after study drug administered. ]

3.  Secondary:   Improvement in Nausea Score From 2 Hours to 24 Hours   [ Time Frame: 2 hours to 24 hours after study drug administered. ]

4.  Secondary:   Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours   [ Time Frame: Baseline to 24 hours after study drug administered. ]

5.  Secondary:   Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)   [ Time Frame: 2 hours after administration of Fosaprepitant 150 mg IV ]

6.  Secondary:   Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)   [ Time Frame: up to 24 hours after receiving fosaprepitant ]

7.  Secondary:   Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant   [ Time Frame: up to 24 hours after study drug administered. ]

8.  Secondary:   Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness   [ Time Frame: up to 24 hours after study drug administered. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
  • Missing data did affect results for the 24 hour mark
  • Lack of control group to measure possible neurokinin-1 antagonist (NK1a) inhibition


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Joseph Bubalo
Organization: Oregon Health & Science University
phone: 503-494-8007
e-mail: bubaloj@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01031953     History of Changes
Obsolete Identifiers: NCT00939302
Other Study ID Numbers: CDR0000612580, P30CA069533, OHSU-HEM-08053-L
Study First Received: December 13, 2009
Results First Received: October 10, 2013
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration