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An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01339260
First received: April 19, 2011
Last updated: November 19, 2014
Last verified: November 2014
Results First Received: November 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Chemotherapy-Induced Nausea and Vomiting
Interventions: Drug: Netupitant and Palonosetron
Drug: Palonosetron
Drug: Dexamethasone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1455 patients randomized (ITT population), 1450 received study drug i.e. netupitant/palonosetron combination or palonosetron, both with dexamethasone, in cycle 1 (safety population-cycle 1), 1449 received chemotherapy and study drug (FAS), 1286 received study drug in multi-cycle extension (safety population-multi-cycle extension)

Reporting Groups
  Description
Netupitant and Palonosetron Plus Dexamethasone

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Palonosetron Plus Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone


Participant Flow for 2 periods

Period 1:   Cycle 1
    Netupitant and Palonosetron Plus Dexamethasone   Palonosetron Plus Dexamethasone
STARTED   726 [1]   729 [1] 
Safety Population   725 [2]   725 [3] 
Full Analysis Set   724 [4]   725 [5] 
COMPLETED   719   719 
NOT COMPLETED   7   10 
[1] Intent-To-Treat: randomized patients
[2] Patients receiving netupitant/palonosetron combination
[3] Patients receiving palonosetron
[4] Patients receiving chemotherapy and randomized to netupitant/palonosetron combination
[5] Patients receiving chemotherapy and randomized to palonosetron

Period 2:   Multi-cycle Extension
    Netupitant and Palonosetron Plus Dexamethasone   Palonosetron Plus Dexamethasone
STARTED   635 [1]   651 [2] 
Safety Population   635 [3]   651 [4] 
COMPLETED   449 [5]   458 [5] 
NOT COMPLETED   186   193 
[1] Patients scheduled to netupitant/palonosetron combination
[2] Patients scheduled to palonosetron
[3] Patients receiving netupitant/palonosetron combination
[4] Patients receiving palonosetron
[5] Patients completing at least number of cycles they were scheduled to



  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.
Safety population ie patients receiving either netupitant/palonosetron combination or palonosetron, both plus dexamethasone

Reporting Groups
  Description
Netupitant and Palonosetron Plus Dexamethasone

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle

Netupitant and Palonosetron

Dexamethasone

Palonosetron Plus Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle

Palonosetron

Dexamethasone

Total Total of all reporting groups

Baseline Measures
   Netupitant and Palonosetron Plus Dexamethasone   Palonosetron Plus Dexamethasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 725   725   1450 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.7  (10.66)   54.1  (10.65)   53.9  (10.65) 
Gender 
[Units: Participants]
     
Female   711   711   1422 
Male   14   14   28 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   574   579   1153 
Black   1   3   4 
Asian   101   103   204 
Hispanic   46   36   82 
Other   3   4   7 


  Outcome Measures
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1.  Primary:   Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1   [ Time Frame: 25-120 hours ]

2.  Secondary:   Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1   [ Time Frame: 0-24 hours ]

3.  Secondary:   Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1   [ Time Frame: 0-120 hours ]


  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
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  More Information
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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: Head of Clinical Development
Organization: Helsinn Healthcare SA
phone: +41 91 9852121
e-mail: marco.palmas@helsinn.com



Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01339260     History of Changes
Other Study ID Numbers: NETU-08-18
Study First Received: April 19, 2011
Results First Received: November 6, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Belarus: Ministry of Health
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Hungary: National Institute of Pharmacy
Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Romania: Ethics Committee
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Poland: National Institute of Medicines
Poland: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Ukraine: Ethics Committee
Ukraine: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Mexico: Ministry of Health
Mexico: Ethics Committee
India: Central Drugs Standard Control Organization
India: Institutional Review Board