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Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01404650
First received: July 21, 2011
Last updated: August 10, 2016
Last verified: August 2016
Results First Received: May 13, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Intervention: Drug: AUY922

  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
This multi-center trial evaluated AUY922 monotherapy as treatment for patients with gastrointestinal stromal tumor (GIST) refractory to, or intolerant of, imatinib and sunitinib. Between Dec 2011 and Jan 2015, 25 patients enrolled in the trial. Thirty-four patients (34) were planned to be enrolled but enrollment stopped early due to slow accrual.

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
AUY922 AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.

Participant Flow:   Overall Study
    AUY922
STARTED   25 [1] 
COMPLETED   25 
NOT COMPLETED   0 
[1] Twenty-five patients received a median of 2 cycles of AUY922.



  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
AUY922 AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.

Baseline Measures
   AUY922 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   9 
Age 
[Units: Years]
Median (Full Range)
 63 
 (20 to 79) 
Gender 
[Units: Participants]
 
Female   11 
Male   14 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   5 
White   20 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   25 


  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years. ]

2.  Secondary:   Response Rate (RR)   [ Time Frame: At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years. ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Every 3 months until patient death or lost to follow-up, for up to 4 years. ]

4.  Secondary:   Number of Patients With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation. ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Johanna Bendell, MD
Organization: Sarah Cannon Research Institute
phone: 877-691-7274
e-mail: asksarah@sarahcannon.com



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01404650     History of Changes
Other Study ID Numbers: SCRI GI 148
Study First Received: July 21, 2011
Results First Received: May 13, 2016
Last Updated: August 10, 2016
Health Authority: United States: Food and Drug Administration