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Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma

This study has been terminated.
(Study terminated prematurely by sponsor for business reason. One patient was enrolled.)
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00746590
First received: September 3, 2008
Last updated: May 3, 2016
Last verified: May 2016
Results First Received: May 3, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Intervention: Drug: Prolarix (tretazicar co-administered with caricotamide)

  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
No text entered.

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
Prolarix Treatment Group Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression

Participant Flow:   Overall Study
    Prolarix Treatment Group  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Death                 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
Prolarix Treatment Group Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression

Baseline Measures
    Prolarix Treatment Group  
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     0  
Male     1  



  Outcome Measures

1.  Primary:   Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST   [ Time Frame: every 6 weeks until progression ]

2.  Secondary:   Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease   [ Time Frame: Approximately 12 weeks or more after first treatment with Prolarix ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Tumour Progression   [ Time Frame: Every 3 weeks until progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour   [ Time Frame: Every 6 weeks until progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Alpha Fetoprotein   [ Time Frame: Baseline, every 3 weeks until progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Adverse Events   [ Time Frame: Until progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Changes in Laboratory Measurements   [ Time Frame: Baseline and every 3 weeks until progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Claire Daugherty
Organization: BTG International Ltd.
phone: +1 801 556 8882
e-mail: claire.daugherty@btgplc.com



Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00746590     History of Changes
Other Study ID Numbers: PR003-CLN-pro001
Study First Received: September 3, 2008
Results First Received: May 3, 2016
Last Updated: May 3, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products