Recruitment

Recruitment Status
Completed

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).
Life expectancy of ≥ 6 weeks.
Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
...
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).
Life expectancy of ≥ 6 weeks.
Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
Serum albumin ≥ 2.8 g/dL
Total bilirubin ≤ 3.0 mg/dL
Cirrhosis classified as Child-Pugh Class B (Appendix C).
Prothrombin time (PT) no greater than 6 seconds longer than control.
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Males and females at least 18 years of age.
Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
Serum creatinine ≤ 2.0 mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of normal (ULN)
Platelet count ≥ 75 × 109/L
For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology.
HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.
For subjects with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix E).

Exclusion Criteria

Pregnant or lactating female.
Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
Locoregional treatment within 4 weeks prior to the Baseline Visit.
...
Pregnant or lactating female.
Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
Locoregional treatment within 4 weeks prior to the Baseline Visit.
Receipt of no, or of >1, prior systemic drug therapies for HCC.
Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1, as determined by CTCAE v 4.0.
History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
Use of any investigational agent within 4 weeks prior to the Baseline Visit.
Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the subject inappropriate for entry into this trial.
Active malignancy other than HCC.
Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
Liver transplant.
Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.

Summary

Conditions
Hepatocellular Carcinoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The trial will evaluate the efficacy and safety of CF102 as compared to placebo. Subjects will be randomly assigned in a 2:1 ratio to treatment with oral doses of either CF102 25 mg or matching placebo administered twice daily (BID) for consecutive, 28-day cycles. Subjects will be evaluated regularl...

The trial will evaluate the efficacy and safety of CF102 as compared to placebo. Subjects will be randomly assigned in a 2:1 ratio to treatment with oral doses of either CF102 25 mg or matching placebo administered twice daily (BID) for consecutive, 28-day cycles. Subjects will be evaluated regularly for safety. Tumor imaging will be performed every 8 weeks. Treatment will continue until the subject experiences unacceptable drug-related intolerability. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug, and every attempt will be made to obtain survival data on all randomized subjects. Subjects who discontinue will be followed indefinitely for survival status. The trial will continue until 75 deaths have been recorded.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).
Life expectancy of ≥ 6 weeks.
Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
...
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).
Life expectancy of ≥ 6 weeks.
Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
Serum albumin ≥ 2.8 g/dL
Total bilirubin ≤ 3.0 mg/dL
Cirrhosis classified as Child-Pugh Class B (Appendix C).
Prothrombin time (PT) no greater than 6 seconds longer than control.
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Males and females at least 18 years of age.
Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
Serum creatinine ≤ 2.0 mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of normal (ULN)
Platelet count ≥ 75 × 109/L
For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology.
HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.
For subjects with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix E).

Exclusion Criteria

Pregnant or lactating female.
Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
Locoregional treatment within 4 weeks prior to the Baseline Visit.
...
Pregnant or lactating female.
Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
Locoregional treatment within 4 weeks prior to the Baseline Visit.
Receipt of no, or of >1, prior systemic drug therapies for HCC.
Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1, as determined by CTCAE v 4.0.
History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
Use of any investigational agent within 4 weeks prior to the Baseline Visit.
Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the subject inappropriate for entry into this trial.
Active malignancy other than HCC.
Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
Liver transplant.
Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.

Tracking Information

NCT #
NCT02128958
Collaborators
Not Provided
Investigators
Study Director: Michael H Silverman Can-Fite BioPharma Ltd
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