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Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583543
First Posted: April 24, 2012
Last Update Posted: May 19, 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.
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital
Results First Submitted: March 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ewing's Sarcoma
Intervention: Drug: Olaparib

  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
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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
Olaparib Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.

Participant Flow:   Overall Study
    Olaparib
STARTED   12 
COMPLETED   12 
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.
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Reporting Groups
  Description
Olaparib Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.

Baseline Measures
   Olaparib 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.5  (15.38) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  16.7% 
Male      10  83.3% 


  Outcome Measures
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1.  Primary:   Objective Response Rate of Olaparib   [ Time Frame: 2 years ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Two years ]

3.  Secondary:   Overall Survival   [ Time Frame: Two years ]

4.  Secondary:   Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event   [ Time Frame: 2 years ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Edwin Choy
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: echoy@mgh.harvard.edu


Publications of Results:

Responsible Party: Edwin Choy, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01583543     History of Changes
Other Study ID Numbers: 11-470
First Submitted: April 18, 2012
First Posted: April 24, 2012
Results First Submitted: March 9, 2016
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017