Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin

This study has been terminated.
(Due to slow accrual)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00840450
First received: February 9, 2009
Last updated: November 12, 2012
Last verified: November 2012
Results First Received: August 18, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Gleevec/Paclitaxel

  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
14 patients were enrolled into this study from April 2007 to August 2009 from New York University medical center and affiliated hospitals. Only 12 were evaluable since 2 patients never received treatment because of rapid symptomatic deterioration.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paclitaxel and Imatinib Mesylate (Gleevec) No text entered.

Participant Flow:   Overall Study
    Paclitaxel and Imatinib Mesylate (Gleevec)  
STARTED     12  
COMPLETED     9  
NOT COMPLETED     3  
Adverse Event                 1  
Lack of Efficacy                 2  



  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.
No text entered.

Reporting Groups
  Description
Paclitaxel and Imatinib Mesylate (Gleevec) No text entered.

Baseline Measures
    Paclitaxel and Imatinib Mesylate (Gleevec)  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 8  
Gender  
[units: participants]
 
Female     12  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     12  
Platinum Sensitivity  
[units: Participants]
 
Resistant     10  
Sensitive     2  



  Outcome Measures
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1.  Primary:   the Best Overall Clinical Response   [ Time Frame: 12 weeks ]

2.  Secondary:   Progression-free-tolerance   [ Time Frame: 12 weeks ]

3.  Secondary:   Progression-free-survival at 12 Months   [ Time Frame: up to 12 months ]


  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
Premature closure led to small numbers of subjects analyzed (12 out of 50 targeted accrual number).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Franco Muggia, MD
Organization: NYU Cancer Institute
phone: 212-263-6485
e-mail: franco.muggia@nyumc.org


No publications provided


Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00840450     History of Changes
Other Study ID Numbers: 06-226, CSTI57BUS224
Study First Received: February 9, 2009
Results First Received: August 18, 2011
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board