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A Study of the HSP90 Inhibitor AUY922

This study has been terminated.
(Study halted early due to limited response.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485536
First Posted: December 5, 2011
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: November 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
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
Recruitment Period: August 28, 2016 to June 17, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 26 participants screened for enrollment, five were not eligible therefore excluded from the study before any treatment assignment.

Reporting Groups
  Description
AUY922 AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.

Participant Flow:   Overall Study
    AUY922
STARTED   21 
COMPLETED   17 
NOT COMPLETED   4 
Withdrawal by Subject                3 
Adverse Event                1 



  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 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.

Baseline Measures
   AUY922 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Median (Full Range)
 60 
 (33 to 77) 
Gender 
[Units: Participants]
Count of Participants
 
Female      5  23.8% 
Male      16  76.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Asian   1 
Black   1 
Hispanic   13 
White   15 
Region of Enrollment 
[Units: Participants]
 
United States   21 
Baseline Lymphoma Diagnosis [1] 
[Units: Participants]
Count of Participants
 
DLBCL   14 
PTCL   6 
Unknown   1 
[1] Histologically confirmed participant diagnosis at baseline by Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL)


  Outcome Measures
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1.  Primary:   Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)   [ Time Frame: 56 days ]

2.  Primary:   Overall Response Rate (ORR)   [ Time Frame: Up to 12 cycles or 48 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
Although the study surpassed the first futility endpoint for DLBCL cohort, it was terminated early due to limited responses and significant toxicities witnessed in the entire cohort of the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Yasuhiro Oki, Associate Professor, Lymphoma/Myeloma
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01485536     History of Changes
Other Study ID Numbers: 2011-0467
NCI-2012-00070 ( Registry Identifier: NCI CTRP )
First Submitted: November 29, 2011
First Posted: December 5, 2011
Results First Submitted: November 28, 2016
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017