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A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.

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ClinicalTrials.gov Identifier: NCT00601172
Recruitment Status : Completed
First Posted : January 25, 2008
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Nausea and Vomiting, Chemotherapy-Induced
Interventions: Drug: Casopitant
Drug: Dexamethasone
Drug: Placebo
Drug: Ondansetron

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 89 centers (55 centers in Europe, 30 in North America and 4 in Korea) in 11 countries from 10-March-2008 to 13-April-2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants received ondansetron and dexamethasone as background antiemetic therapy. To assure adequate blinding, placebo to match casopitant was used. Participants were screened within 14 days of first dose of study anti-emetics and were randomly assigned to either single dose intravenous (IV) (90 mg casopitant) or control (placebo).

Reporting Groups
  Description
Placebo Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 milligram [mg] twice daily [BID] orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
Casopitant 90 mg Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.

Participant Flow:   Overall Study
    Placebo   Casopitant 90 mg
STARTED   355   355 
COMPLETED   214   228 
NOT COMPLETED   141   127 
Adverse Event                43                32 
Lack of Efficacy                11                12 
Protocol Violation                2                5 
Lost to Follow-up                4                3 
Physician Decision                27                28 
Withdrawal by Subject                35                27 
Did not meet continuation criteria                19                20 



  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 Age, only 352 participants were analyzed in the Placebo group.

Reporting Groups
  Description
Placebo Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
Casopitant 90 mg Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
Total Total of all reporting groups

Baseline Measures
   Placebo   Casopitant 90 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 355   355   710 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 352   355   707 
   61.3  (10.77)   61.3  (11.03)   61.3  (10.90) 
[1] Age data is presented for modified Intent-to-Treat (mITT) Population which comprised of all participants who were randomized, received any investigational product and had oxaliplatin administered.
[2] N=352
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 355   355   710 
Female      145  40.8%      173  48.7%      318  44.8% 
Male      210  59.2%      182  51.3%      392  55.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 355   355   710 
American Indian or Alaska Native      0   0.0%      1   0.3%      1   0.1% 
Asian      24   6.8%      30   8.5%      54   7.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5   1.4%      6   1.7%      11   1.5% 
White      326  91.8%      318  89.6%      644  90.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen   [ Time Frame: 0 to 120 hours in the first cycle of chemotherapy ]

2.  Secondary:   Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1   [ Time Frame: 0 to 24 hours in the first cycle of chemotherapy ]

3.  Secondary:   Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1   [ Time Frame: 24 to 120 hours (delayed phase) in the first cycle of chemotherapy ]

4.  Secondary:   Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2   [ Time Frame: 0 to 120 hours in the second cycle of chemotherapy ]

5.  Secondary:   Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS)   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

6.  Secondary:   Percentage of Participants Who Received Rescue Medication   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

7.  Secondary:   Percentage of Participants Who Vomited and/or Retched   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

8.  Secondary:   Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

9.  Secondary:   Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

10.  Secondary:   Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

11.  Secondary:   Percentage of Participants Who Achieved Total Control, Defined as Complete Responders Who Had no Nausea   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

12.  Secondary:   Percentage of Participants Whose Daily Life Activities Were Impacted in the Overall Phase of Cycle 1, Assessed by Functional Living Index-Emesis (FLIE) Questionnaire   [ Time Frame: 0 to 120 hours in the first cycle of chemotherapy ]

13.  Secondary:   Severity of Nausea in the Overall, Acute, and Delayed Phases of Cycle 1 Assessed by a Categorical Scale   [ Time Frame: 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy ]

14.  Secondary:   Single-dose Pharmacokinetic (PK) Parameters: Area Under the Curve (AUC) 0 to Infinity (0-∞), AUC 0 to t (0-t) and AUC 0 to 24 Hours (0-24) for Casopitant; AUC (0-t) and AUC (0-24) for Metabolites GSK525060, GSK517142 and GSK631832   [ Time Frame: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion ]

15.  Secondary:   Single-dose Pharmacokinetic Parameters: Maximum Observed Drug Concentration (Cmax) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832   [ Time Frame: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion ]

16.  Secondary:   Single-dose Pharmacokinetic Parameters: Time to Maximum Observed Drug Concentration (Tmax) and Observed Elimination Half-life (t1/2) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832   [ Time Frame: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion ]

17.  Secondary:   Single-dose Pharmacokinetic Parameters: Clearance (CL) for Casopitant   [ Time Frame: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion ]

18.  Secondary:   Single-dose Pharmacokinetic Parameters: Volume of Distribution (Vdss) for Casopitant   [ Time Frame: Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion ]

19.  Secondary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 35 days ]

20.  Secondary:   Number of Participants With Hematology Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4   [ Time Frame: Baseline (Day 1) to Day 24 ]

21.  Secondary:   Number of Participants With Clinical Chemistry Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4   [ Time Frame: Up to Day 24 ]

22.  Secondary:   Evaluation of Vital Signs: Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)   [ Time Frame: Up to End of Cycle for 6 cycles, an average of 24 days per cycle ]

23.  Secondary:   Evaluation of Vital Signs: Mean Heart Rate   [ Time Frame: Up to End of Cycle for 6 cycles, an average of 24 days per cycle ]

24.  Secondary:   Time to First Anti-emetic Rescue Medication   [ Time Frame: 0 to 120 hours in the first cycle of chemotherapy ]

25.  Secondary:   Time to First Emetic Event   [ Time Frame: 0 to 120 hours in the first cycle of chemotherapy ]


  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
No text entered.


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00601172     History of Changes
Other Study ID Numbers: NKV110721
First Submitted: January 15, 2008
First Posted: January 25, 2008
Results First Submitted: September 7, 2017
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018