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

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ClinicalTrials.gov Identifier: NCT00840450
Recruitment Status : Terminated (Due to slow accrual)
First Posted : February 10, 2009
Results First Posted : September 26, 2011
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Gleevec/Paclitaxel

  Participant Flow

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

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) 
Overall Participants Analyzed 
[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

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

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

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



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00840450     History of Changes
Other Study ID Numbers: 06-226
CSTI57BUS224 ( Other Identifier: Novartis )
First Submitted: February 9, 2009
First Posted: February 10, 2009
Results First Submitted: August 18, 2011
Results First Posted: September 26, 2011
Last Update Posted: November 19, 2012