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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790218
First Posted: November 13, 2008
Last Update Posted: February 27, 2015
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.
Information provided by (Responsible Party):
Can-Fite BioPharma
Results First Submitted: August 12, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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.
No text entered.

Reporting Groups
  Description
CF102 CF102: CF102 capsules twice daily by mouth

Baseline Measures
   CF102 
Overall Participants Analyzed 
[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.  

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

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

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.  


  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
No text entered.


  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
First Submitted: November 11, 2008
First Posted: November 13, 2008
Results First Submitted: August 12, 2014
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015



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