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

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.
 
ClinicalTrials.gov Identifier: NCT00746590
Recruitment Status : Terminated (Study terminated prematurely by sponsor for business reason. One patient was enrolled.)
First Posted : September 4, 2008
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatocellular Carcinoma
Intervention Drug: Prolarix (tretazicar co-administered with caricotamide)
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prolarix Treatment Group
Hide Arm/Group Description 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
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Prolarix Treatment Group
Hide Arm/Group Description 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
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST
Hide Description [Not Specified]
Time Frame every 6 weeks until progression
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.
Arm/Group Title Prolarix Group
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: participants
NA [1]   (NA)
[1]
Study was terminated--the one patient enrolled before termination died after initial dose.
2.Secondary Outcome
Title Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease
Hide Description [Not Specified]
Time Frame Approximately 12 weeks or more after first treatment with Prolarix
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Tumour Progression
Hide Description [Not Specified]
Time Frame Every 3 weeks until progression
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour
Hide Description [Not Specified]
Time Frame Every 6 weeks until progression
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes in Alpha Fetoprotein
Hide Description [Not Specified]
Time Frame Baseline, every 3 weeks until progression
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame Until progression
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Changes in Laboratory Measurements
Hide Description [Not Specified]
Time Frame Baseline and every 3 weeks until progression
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prolarix Treatment Group
Hide Arm/Group Description 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
All-Cause Mortality
Prolarix Treatment Group
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Prolarix Treatment Group
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
GI toxicity [1]  1/1 (100.00%)  1
[1]
Patient developed GI toxicity resulting in hospitalization considered to be possibly related to study treatment and manifested by dehydration, nausea, anorexia, fatigue, vomiting, diarrhea, and deterioration in performance status (ECOG 3).
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prolarix Treatment Group
Affected / at Risk (%) # Events
Total   0/0    
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
Layout table for Results Point of Contact information
Name/Title: Claire Daugherty
Organization: BTG International Ltd.
Phone: +1 801 556 8882
EMail: claire.daugherty@btgplc.com
Layout table for additonal information
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00746590    
Other Study ID Numbers: PR003-CLN-pro001
First Submitted: September 3, 2008
First Posted: September 4, 2008
Results First Submitted: May 3, 2016
Results First Posted: June 9, 2016
Last Update Posted: June 9, 2016