Trial record 1 of 97 for:    PALO-10-20
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Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01442376
First received: September 21, 2011
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Chemotherapy-Induced Nausea and Vomiting
Interventions: Drug: Palonosetron
Drug: Ondansetron
Drug: Placebo to Ondansetron
Drug: Placebo to Palonosetron

  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
A total of 502 patients were enrolled and randomly assigned to treatment. Study drug was not administered to 8 randomized patients, of these patients 2 had also an adverse event and were counted under this category in overall study statement. Therefore 494 patients did receive the study drug and are part of the analysis for the safety population.

Reporting Groups
  Description
Palonosetron 10 mcg/kg

Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron

Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg

Placebo to Ondansetron

Palonosetron 20 mcg/kg

Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron

Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg

Placebo to Ondansetron

Ondansetron

Ondansetron and placebo to Palonosetron

Drug:

Comparator: Ondansetron

Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg

Placebo to Palonosetron


Participant Flow:   Overall Study
    Palonosetron 10 mcg/kg     Palonosetron 20 mcg/kg     Ondansetron  
STARTED     169 [1]   169 [1]   164 [1]
COMPLETED     166     160     159  
NOT COMPLETED     3     9     5  
Adverse Event                 0                 3                 2  
Death                 0                 1                 1  
Withdrawal of consent                 0                 0                 1  
Patients not treated                 2                 3                 1  
Not eligible for subsequent cycles                 1                 2                 0  
[1] Randomized patients



  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.
Full Analysis Set (FAS) population which included all randomized patients receiving the active study drug and HEC or MEC. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the randomized treatment.

Reporting Groups
  Description
Palonosetron 10 mcg/kg

Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron

Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg

Placebo to Ondansetron

Palonosetron 20 mcg/kg

Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron

Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg

Placebo to Ondansetron

Ondansetron

Ondansetron and placebo to Palonosetron

Drug:

Comparator: Ondansetron

Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg

Placebo to Palonosetron

Total Total of all reporting groups

Baseline Measures
    Palonosetron 10 mcg/kg     Palonosetron 20 mcg/kg     Ondansetron     Total  
Number of Participants  
[units: participants]
  166     165     162     493  
Age, Customized  
[units: participants]
       
<2 years     15     15     15     45  
2 to <6 years     54     54     54     162  
6 to <12 years     46     46     44     136  
12 to <17 years     51     50     49     150  
Gender  
[units: participants]
       
Female     88     76     98     262  
Male     78     89     64     231  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     26     26     12     64  
Not Hispanic or Latino     140     139     150     429  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     2     0     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     2     0     0     2  
White     156     154     159     469  
More than one race     5     11     3     19  
Unknown or Not Reported     1     0     0     1  
Emetogenicity of chemotherapy in Cycle 1  
[units: participants]
       
MEC     112     116     111     339  
HEC     54     49     51     154  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1   [ Time Frame: 0 to 24 hours after T0 ]

2.  Secondary:   Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1   [ Time Frame: from >24 to 120 hours (delayed phase) after T0 ]


  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
No text entered.


  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: Spinelli Tulla
Organization: Helsinn Healthcare SA
phone: +4191985 21 21
e-mail: tulla.spinelli@helsinn.com


No publications provided


Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01442376     History of Changes
Other Study ID Numbers: PALO-10-20
Study First Received: September 21, 2011
Results First Received: June 27, 2014
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Estonia: The State Agency of Medicine
Czech Republic: State Institute for Drug Control
Austria: Federal Office for Safety in Health Care
Chile: Instituto de Salud Pública de Chile
Romania: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Ukraine: Ministry of Health
Germany: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Peru: Instituto Nacional de Salud
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency