Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01281865
First received: January 21, 2011
Last updated: October 3, 2014
Last verified: June 2013
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Synovial Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions: Other: diagnostic laboratory biomarker analysis
Drug: everolimus
Drug: imatinib mesylate

  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
Protocol Open to Accrual: 01/20/2011 Protocol Closed to Accrual: 10/23/2012 Primary Completion Date (if applicable):10/22/2013 Recruitment Location is the medical clinic

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
Arm 1-Treatment (Everolimus and Imatinib Mesylate) Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
Arm 2-Treatment (Everolimus and Imatinib Mesylate) Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD

Participant Flow:   Overall Study
    Arm 1-Treatment (Everolimus and Imatinib Mesylate)     Arm 2-Treatment (Everolimus and Imatinib Mesylate)  
STARTED     12     2  
COMPLETED     9     1  
NOT COMPLETED     3     1  
Adverse Event                 1                 1  
Withdrawal by Subject                 1                 0  
Lack of Efficacy                 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.
No text entered.

Reporting Groups
  Description
Arm 1-Treatment (Everolimus and Imatinib Mesylate) Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
Arm 2-Treatment (Everolimus and Imatinib Mesylate) Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
Total Total of all reporting groups

Baseline Measures
    Arm 1-Treatment (Everolimus and Imatinib Mesylate)     Arm 2-Treatment (Everolimus and Imatinib Mesylate)     Total  
Number of Participants  
[units: participants]
  12     2     14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     2     13  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     6     1     7  
Male     6     1     7  
Region of Enrollment  
[units: participants]
     
United States     12     2     14  



  Outcome Measures

1.  Primary:   Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)   [ Time Frame: At 8 weeks ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mary Keohan
Organization: Memorial Sloan-Kettering Cancer Center
phone: 646-888-4160
e-mail: keohanm@mskcc.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01281865     History of Changes
Other Study ID Numbers: NCI-2011-02577, NCI-2011-02577, CDR0000693826, 10-167, 8603, P30CA008748, U01CA069856
Study First Received: January 21, 2011
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration