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Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01560260
First received: March 20, 2012
Last updated: November 18, 2016
Last verified: November 2016
Results First Received: November 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Carney Complex
Chondrosarcoma
Gastrointestinal Stromal Tumor
Paraganglioma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Linsitinib
Other: Pharmacological Study

  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
No text entered.

Reporting Groups
  Description
Treatment (Linsitinib)

Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Linsitinib: Given PO

Pharmacological Study: Correlative studies


Participant Flow:   Overall Study
    Treatment (Linsitinib)
STARTED   20 
COMPLETED   20 
NOT COMPLETED   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
Treatment (Linsitinib)

Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Linsitinib: Given PO

Pharmacological Study: Correlative studies


Baseline Measures
   Treatment (Linsitinib) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1   5.0% 
Between 18 and 65 years      19  95.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (13) 
Gender 
[Units: Participants]
Count of Participants
 
Female      12  60.0% 
Male      8  40.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Response Rate (CR or PR) Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1   [ Time Frame: At 6 months ]

2.  Secondary:   Clinical Benefit Rate Defined as SD >= 9 Months, PR or CR   [ Time Frame: Up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Failure-free Survival   [ Time Frame: Up to 37 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   OS   [ Time Frame: Up to 37 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   PFS   [ Time Frame: Time from date of enrollment to time of progression or death due to any cause, assessed up to 37 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Response Duration   [ Time Frame: Up to 37 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Time to Progression   [ Time Frame: Up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Kristen Nuyen, Research Project Manager
Organization: Sarcoma Alliance for Research through Collaboration (SARC)
phone: 734-930-7600
e-mail: sarc@sarctrials.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01560260     History of Changes
Other Study ID Numbers: NCI-2012-00708
NCI-2012-00708 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000728619
SARC-022
SARC 022
SARC022 ( Other Identifier: Sarcoma Alliance for Research Through Collaboration )
8945 ( Other Identifier: CTEP )
Study First Received: March 20, 2012
Results First Received: November 18, 2016
Last Updated: November 18, 2016