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Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01206140
First received: September 18, 2010
Last updated: September 4, 2015
Last verified: January 2015
Results First Received: July 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Selumetinib
Drug: Temsirolimus

  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
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Reporting Groups
  Description
Arm I (Selumetinib)

Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Arm II (Selumetinib and Temsirolimus)

Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Temsirolimus: Given IV


Participant Flow:   Overall Study
    Arm I (Selumetinib)     Arm II (Selumetinib and Temsirolimus)  
STARTED     35     35  
COMPLETED     34     35  
NOT COMPLETED     1     0  
Deemed ineligible due to incorrect diag.                 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 I (Selumetinib)

Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Arm II (Selumetinib and Temsirolimus)

Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Temsirolimus: Given IV

Total Total of all reporting groups

Baseline Measures
    Arm I (Selumetinib)     Arm II (Selumetinib and Temsirolimus)     Total  
Number of Participants  
[units: participants]
  34     35     69  
Age  
[units: years]
Median (Full Range)
  56  
  (34 to 84)  
  56  
  (20 to 83)  
  56  
  (20 to 84)  
Gender  
[units: participants]
     
Female     17     25     42  
Male     17     10     27  
Region of Enrollment  
[units: participants]
     
United States     34     35     69  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Until disease progression or death, up to 4.5 years ]

2.  Secondary:   Number of Participants With Objective Response   [ Time Frame: Evaluated for response after every two cycles, up to 4.5 years. ]

3.  Secondary:   4 -Month Progression-free Survival Rate.   [ Time Frame: Four 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
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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: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01206140     History of Changes
Other Study ID Numbers: NCI-2011-02532
NCI-2011-02532 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000685408
CHNMC-PHII-95
NCCN-T06
PHII-95 ( Other Identifier: City of Hope Comprehensive Cancer Center )
8412 ( Other Identifier: CTEP )
N01CM00038 ( US NIH Grant/Contract Award Number )
P30CA033572 ( US NIH Grant/Contract Award Number )
Study First Received: September 18, 2010
Results First Received: July 27, 2015
Last Updated: September 4, 2015
Health Authority: United States: Food and Drug Administration