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Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer

This study has been terminated.
(Administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471197
First received: November 10, 2011
Last updated: April 14, 2014
Last verified: April 2014
Results First Received: March 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer - Non Small Cell
Interventions: Biological: Ipilimumab
Biological: Pemetrexed

  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
Study started July 2012 and completed February 2013. After 9 participants enrolled, the study was terminated for administrative reasons unrelated to adverse events (AEs) or expectation of efficacy associated with either ipilimumab or pemetrexed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
9 participants enrolled; 8 participants randomized; 1 participant not randomized due to disease progression and death.

Reporting Groups
  Description
Ipilimumab 10 mg/kg Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
Pemetrexed 500 mg/m^2 Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.

Participant Flow:   Overall Study
    Ipilimumab 10 mg/kg     Pemetrexed 500 mg/m^2  
STARTED     6     2  
COMPLETED     0     0  
NOT COMPLETED     6     2  
Disease Progression                 4                 2  
Death                 1                 0  
Study Drug Toxicity                 1                 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.
Randomized participants who received at least one dose of either study medication.

Reporting Groups
  Description
Ipilimumab 10 mg/kg Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
Pemetrexed 500 mg/m^2 Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Total Total of all reporting groups

Baseline Measures
    Ipilimumab 10 mg/kg     Pemetrexed 500 mg/m^2     Total  
Number of Participants  
[units: participants]
  6     2     8  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 8.85     61.0  ± 1.41     62.3  ± 7.54  
Age, Customized  
[units: participants]
     
Less than (<) 65 years     4     2     6  
Greater than, equal to (>=) 65 years     2     0     2  
Gender  
[units: participants]
     
Female     2     1     3  
Male     4     1     5  
Eastern Cooperative Oncology Group Performance Status [1]
[units: participants]
     
ECOG PS 0     3     1     4  
ECOG PS 1     3     1     4  
[1] Eastern Cooperative Oncology Group Performance Status (ECOG PS) is a questionnaire which measures the activity of a an oncology patient. Measurements range from 0 to 5 with 0=fully active; 1= restricted in physically strenuous activity; 2= ambulatory; 3=limited self care; 4= completely disabled; 5=dead.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival of Participants During the Study - All Treated Participants   [ Time Frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started ]

2.  Secondary:   Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants   [ Time Frame: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started. ]

3.  Secondary:   Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants   [ Time Frame: Day 1 to Date of last patient, last visit, approximately 7 months after study started. ]


  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
At the time of the early termination of this study, most participants only had only one on-study tumor assessment performed. Therefore, the tumor response-related endpoints were too immature to report.


  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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01471197     History of Changes
Other Study ID Numbers: CA184-124 ST, 2011-000732-29
Study First Received: November 10, 2011
Results First Received: March 6, 2014
Last Updated: April 14, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Poland: Ministry of Science and Higher Education
Poland: National Institute of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
United States: Institutional Review Board
United States: Food and Drug Administration