Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00290771
First received: February 10, 2006
Last updated: April 20, 2011
Last verified: April 2011
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Glioblastoma Multiforme (GBM)
Interventions: Drug: Imatinib tablets
Drug: Hydroxyurea capsules

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Imatinib 600 mg + Hydroxyurea 1000 mg Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
Imatinib 1000 mg + Hydroxyurea 1000 mg Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.

Participant Flow:   Overall Study
    Imatinib 600 mg + Hydroxyurea 1000 mg     Imatinib 1000 mg + Hydroxyurea 1000 mg  
STARTED     131     100  
COMPLETED     4     3  
NOT COMPLETED     127     97  
Disease progression                 95                 73  
Death                 11                 10  
Adverse Event                 12                 6  
Withdrawal by Subject                 5                 6  
Administrative problems                 2                 1  
Protocol Violation                 2                 0  
Lost to Follow-up                 0                 1  



  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.
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Reporting Groups
  Description
Imatinib 600 mg + Hydroxyurea 1000 mg Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
Imatinib 1000 mg + Hydroxyurea 1000 mg Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
Total Total of all reporting groups

Baseline Measures
    Imatinib 600 mg + Hydroxyurea 1000 mg     Imatinib 1000 mg + Hydroxyurea 1000 mg     Total  
Number of Participants  
[units: participants]
  131     100     231  
Age  
[units: years]
Mean ± Standard Deviation
  53.7  ± 11.9     52.8  ± 11.4     53.3  ± 11.7  
Gender  
[units: participants]
     
Female     52     35     87  
Male     79     65     144  



  Outcome Measures
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1.  Primary:   Percentage of Patients With an Objective Overall Response (OOR)   [ Time Frame: Baseline to end of study (Month 24) ]

2.  Secondary:   Duration of Objective Overall Response (OOR)   [ Time Frame: Baseline to end of study (Month 24) ]

3.  Secondary:   Percentage of Patients Who Had Clinical Benefit   [ Time Frame: Baseline to end of study (Month 24) ]

4.  Secondary:   Percentage of Patients With Progression-free Survival at Months 6 and 12   [ Time Frame: Months 6 and 12 ]

5.  Secondary:   Percentage of Patients Surviving at Months 6, 12, and 24   [ Time Frame: Months 6, 12, and 24 ]

6.  Secondary:   Number of Patients With at Least 1 Adverse Event   [ Time Frame: Baseline to end of study (Month 24) ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00290771     History of Changes
Obsolete Identifiers: NCT00292149
Other Study ID Numbers: CSTI571H2201, CSTI571H2202
Study First Received: February 10, 2006
Results First Received: December 20, 2010
Last Updated: April 20, 2011
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada
Switzerland: Swissmedic
Australia: Department of Health and Ageing Therapeutic Goods Administration