A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT00790218
First received: November 11, 2008
Last updated: February 26, 2015
Last verified: August 2014
Results First Received: August 12, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Intervention: Drug: CF102

  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
No text entered.

Reporting Groups
  Description
CF102 1mg CF102: CF102 tablets were given orally twice daily
CF102 5mg CF102: CF102 tablets were given orally twice daily
CF102 25mg CF102: CF102 tablets were given orally twice daily

Participant Flow:   Overall Study
    CF102 1mg     CF102 5mg     CF102 25mg  
STARTED     6     6     7  
COMPLETED     5     6     7  
NOT COMPLETED     1     0     0  
Death                 1                 0                 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
CF102 CF102: CF102 capsules twice daily by mouth

Baseline Measures
    CF102  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     12  
Gender  
[units: participants]
 
Female     7  
Male     12  
Region of Enrollment  
[units: participants]
 
Israel     19  



  Outcome Measures

1.  Primary:   Dose Limiting Toxicity   [ Time Frame: From start of treatment until Day 28 of Cycle 1 ]

2.  Primary:   Repeat-dose Pharmacokinetic Behavior of CF102   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Maximum Tolarated Dose   [ Time Frame: first 28 days (Cycle 1) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Therapeutic Effect of CF102 in Hepatocellular Carcinoma   [ Time Frame: Every 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Sari Fishman, Director of Clincal Trials
Organization: Can-Fite BioPharma
phone: 972528998666
e-mail: sari@canfite.co.il


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00790218     History of Changes
Other Study ID Numbers: CF102-102HCC
Study First Received: November 11, 2008
Results First Received: August 12, 2014
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health