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A Phase 1-2 Study of CF102 in Patients With Advanced 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: NCT00790218
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatocellular Carcinoma
Intervention Drug: CF102
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CF102 1mg CF102 5mg CF102 25mg
Hide Arm/Group Description CF102: CF102 tablets were given orally twice daily CF102: CF102 tablets were given orally twice daily CF102: CF102 tablets were given orally twice daily
Period Title: Overall Study
Started 6 6 7
Completed 5 6 7
Not Completed 1 0 0
Reason Not Completed
Death             1             0             0
Arm/Group Title CF102
Hide Arm/Group Description CF102: CF102 capsules twice daily by mouth
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  36.8%
>=65 years
12
  63.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
7
  36.8%
Male
12
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 19 participants
19
1.Primary Outcome
Title Dose Limiting Toxicity
Hide Description Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1
Time Frame From start of treatment until Day 28 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CF102 1mg CF102 5mg CF102 25mg
Hide Arm/Group Description:
CF102 tablets given orally, BID
CF102 tablets given orally, BID
CF102 tablets given orally, BID
Overall Number of Participants Analyzed 6 6 7
Measure Type: Number
Unit of Measure: participants
0 0 0
2.Primary Outcome
Title Repeat-dose Pharmacokinetic Behavior of CF102
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
3.Primary Outcome
Title Maximum Tolarated Dose
Hide Description The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.
Time Frame first 28 days (Cycle 1)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Therapeutic Effect of CF102 in Hepatocellular Carcinoma
Hide Description [Not Specified]
Time Frame Every 2 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102
Hide Description [Not Specified]
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame As long as the patients were on the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CF102 1mg CF102 5mg CF102 25mg
Hide Arm/Group Description CF102: CF102 capsules twice daily by mouth CF102: CF102 capsules twice daily by mouth CF102: CF102 capsules twice daily by mouth
All-Cause Mortality
CF102 1mg CF102 5mg CF102 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CF102 1mg CF102 5mg CF102 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   6/6 (100.00%)   3/7 (42.86%) 
Gastrointestinal disorders       
Hospitalization due to ascites paracentesis * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Ascites * 1  0/6 (0.00%)  2/6 (33.33%)  1/7 (14.29%) 
Vomiting * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
General disorders       
Fatigue * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Infections and infestations       
UTI * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Injury, poisoning and procedural complications       
Pathological fracture sacrum * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders       
Inflammation – knee * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Fistula * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Nervous system disorders       
Headache * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Vascular disorders       
Thrombus – left leg * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CF102 1mg CF102 5mg CF102 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders       
Petechiae * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Anemia * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Cardiac disorders       
Cardiac arrest * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Gastrointestinal disorders       
Constipation * 1  1/6 (16.67%)  0/6 (0.00%)  2/7 (28.57%) 
Abdominal pain * 1  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Diarrhoea * 1  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Nausea * 1  2/6 (33.33%)  0/6 (0.00%)  0/7 (0.00%) 
Ascites * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Dry mouth * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Pelvic pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Vomiting * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Abdominal distension * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Umbilical hernia * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Haematochezia * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Haemorrhoids * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Abdominal distension * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Gastrointestinal Haemorrhage * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
General disorders       
Fatigue * 1  1/6 (16.67%)  2/6 (33.33%)  2/7 (28.57%) 
Asthenia * 1  0/6 (0.00%)  2/6 (33.33%)  2/7 (28.57%) 
Pyrexia * 1  2/6 (33.33%)  1/6 (16.67%)  0/7 (0.00%) 
Chest pain * 1  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Oedema * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Oedema peripheral * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
General Physical Health Deterioration * 1  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Hepatobiliary disorders       
Hepatic Cirrhosis * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Portal vein thrombosis * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Immune system disorders       
Hypersensitivity * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Infections and infestations       
Influenza * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Viral infection * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Cellulitis * 1  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%) 
Fungal Infection * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Sepsis * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Sinusitis * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications       
Hand fracture * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pathological Fracture * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/6 (16.67%)  1/6 (16.67%)  2/7 (28.57%) 
Hyponatraemia * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Hyperkalaemia * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Muscle contracture * 1  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Arthralgia * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Pain in extremity * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Bone pain * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Buttock Pain * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Nervous system disorders       
Cerebral haemorrhage * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Dizziness * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Dysgeusia * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Headache * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Neuropathy peripheral * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Cerebrovascular accident * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Presyncope * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Hepatic encephalopathy * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Syncope * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Psychiatric disorders       
Depression * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Renal and urinary disorders       
Pollakiuria * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Oliguria * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Renal failure * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Urinary Retention * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Haematuria * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Reproductive system and breast disorders       
Nipple pain * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Epistaxis * 1  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Rhinitis * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Oropharyngeal pain * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Dyspnoea * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Dyspnoea * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Acne * 1  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Hyperhidrosis * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Rash pruritic * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Rash * 1  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
Vascular disorders       
Thrombosis * 1  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v 9.0
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: Sari Fishman, Director of Clincal Trials
Organization: Can-Fite BioPharma
Phone: 972528998666
EMail: sari@canfite.co.il
Layout table for additonal information
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