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Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

This study has been terminated.
(Study terminated based on evaluation of safety data.)
Sponsor:
Information provided by (Responsible Party):
Ariad Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01650805
First received: July 18, 2012
Last updated: November 5, 2014
Last verified: October 2014
Results First Received: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Myeloid Leukemia
Interventions: Drug: ponatinib
Drug: imatinib (Gleevec/ Glivec)

  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 307 subjects were enrolled (ponatinib patients: 155; imatinib patients: 152). Patients were randomized in a 1:1 fashion to receive either ponatinib or imatinib.

Reporting Groups
  Description
Ponatinib ponatinib: 45 mg tablet, taken orally once daily
Imatinib imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily

Participant Flow:   Overall Study
    Ponatinib   Imatinib
STARTED   155 [1]   152 
COMPLETED   154 [2]   152 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 
[1] Started means patient has been randomized.
[2] Completed means patient initiated and discontinued study treatment.



  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.
ITT Population

Reporting Groups
  Description
Ponatinib ponatinib: 45 mg tablet, taken orally once daily
Imatinib imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
Total Total of all reporting groups

Baseline Measures
   Ponatinib   Imatinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   152   307 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   119   116   235 
>=65 years   36   36   72 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.9  (15.66)   51.2  (15.19)   51.5  (15.41) 
Gender 
[Units: Participants]
     
Female   58   60   118 
Male   97   92   189 
Region of Enrollment 
[Units: Participants]
     
Portugal   0   2   2 
United States   48   34   82 
Hong Kong   4   1   5 
Taiwan   3   2   5 
Finland   1   0   1 
Spain   16   9   25 
Italy   15   14   29 
United Kingdom   6   12   18 
France   14   21   35 
Czech Republic   1   3   4 
Canada   16   13   29 
Poland   0   1   1 
Belgium   3   2   5 
Singapore   1   11   12 
Australia   1   6   7 
Netherlands   1   1   2 
Germany   11   12   23 
New Zealand   4   4   8 
Sweden   6   2   8 
Korea, Republic of   3   2   5 
Switzerland   1   0   1 


  Outcome Measures
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1.  Primary:   Major Molecular Response (MMR) Rate at 12 Months   [ Time Frame: 12 months after first dose ]

2.  Secondary:   <10% BCR-ABL^IS Rate   [ Time Frame: 3 months after first dose ]

3.  Secondary:   Complete Cytogenetic Response (CCyR) Rate   [ Time Frame: 12 months after first dose ]

4.  Secondary:   MMR Rate   [ Time Frame: 5 years after first dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Progression-free Survival   [ Time Frame: Up to 8 years after the last patient’s first dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Overall Survival   [ Time Frame: Up to 8 years after the last patient’s first dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Trial was discontinued early.


  More Information
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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: Maureen Conlan, Senior Medical Director
Organization: ARIAD Pharmaceuticals, Inc.
phone: 1-617-621-2316
e-mail: Maureen.Conlan@ariad.com



Responsible Party: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01650805     History of Changes
Other Study ID Numbers: AP24534-12-301
Study First Received: July 18, 2012
Results First Received: October 15, 2014
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medicines and Medical Devices Safety Authority
Taiwan: National Laboratories of Foods and Drugs
Israel: Israeli Health Ministry Pharmaceutical Administration
Hong Kong: Department of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
Switzerland: Swissmedic