Voraxaze for Delayed Methotrexate Clearance

This study has been terminated.
(Sponsor terminated due to low accrual.)
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00424645
First received: January 17, 2007
Last updated: December 4, 2012
Last verified: December 2012
Results First Received: November 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Hematologic Malignancy
Solid Tumor
Interventions: Drug: Voraxaze (Glucarpidase)
Drug: Placebo

  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: 01/09/07 through 01/31/08. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study closed early by sponsor due to low accrual. Of three patients enrolled, only two patients received blinded study drug. Study terminated prior to other randomization.

Reporting Groups
  Description
Voraxaze Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
Placebo Placebo administered IV following Voraxaze arm.

Participant Flow:   Overall Study
    Voraxaze     Placebo  
STARTED     3     0  
COMPLETED     2     0  
NOT COMPLETED     1     0  
Death                 1                 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
Voraxaze Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
Placebo Placebo administered IV following Voraxaze arm.
Total Total of all reporting groups

Baseline Measures
    Voraxaze     Placebo     Total  
Number of Participants  
[units: participants]
  3     0     3  
Age  
[units: years]
Mean ( Full Range )
  64  
  ( 46 to 72 )  
   
   
  64  
  ( 46 to 72 )  
Gender  
[units: participants]
     
Female     0         0  
Male     3         3  
Region of Enrollment  
[units: participants]
     
United States     3         3  



  Outcome Measures

1.  Primary:   Patient Response Rate (Percentage)   [ Time Frame: Study period 2 years ]


  Serious Adverse Events


  Other Adverse Events


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


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
No text entered.  


Results Point of Contact:  
Name/Title: Saroj Vadhan, MD
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00424645     History of Changes
Other Study ID Numbers: 2006-0119
Study First Received: January 17, 2007
Results First Received: November 9, 2010
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration