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Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onconova Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00856791
First received: March 4, 2009
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
Results First Received: November 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: ON 01910.Na

  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
The study was conducted at one site in the United States. One patient was enrolled and treated, after which, the study was closed due to slow enrollment.

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
ON 01910.Na 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle

Participant Flow:   Overall Study
    ON 01910.Na  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
ON 01910.Na 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle

Baseline Measures
    ON 01910.Na  
Number of Participants  
[units: participants]
 		  1  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     1  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Adverse Events   [ Time Frame: 6 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Francois E. Wilhelm, MD, PhD
Organization: Onconova Therapeutics, Inc.
phone: 609 281-7086
e-mail: fwilhelm@onconova.us


Publications:


Responsible Party: Onconova Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00856791     History of Changes
Other Study ID Numbers: Onconova 04-12
Study First Received: March 4, 2009
Results First Received: November 27, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration