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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01031953
Recruitment Status : Terminated (Drug contract timelines and inadequate enrollment)
First Posted : December 15, 2009
Results First Posted : January 30, 2014
Last Update Posted : May 9, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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
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

  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.
No text entered.

Reporting Groups
Fosaprepitant No text entered.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      10  90.9% 
>=65 years      1   9.1% 
[Units: Years]
Mean (Standard Deviation)
 45  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      5  45.5% 
Male      6  54.5% 
Region of Enrollment 
[Units: Participants]
United States   11 

  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

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

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

Responsible Party: Joseph Bubalo, OHSU Knight Cancer Institute Identifier: NCT01031953     History of Changes
Obsolete Identifiers: NCT00939302
Other Study ID Numbers: CDR0000612580
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-HEM-08053-L ( Other Identifier: OHSU 4498 )
First Submitted: December 13, 2009
First Posted: December 15, 2009
Results First Submitted: October 10, 2013
Results First Posted: January 30, 2014
Last Update Posted: May 9, 2017