Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: CF102; Placebo
Intervention description: orally q12h; orally q12 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; Child-Pugh Class B Cirrhosis

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in
      subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1
      prior systemic drug therapy for HCC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females at least 18 years of age.

          2. Diagnosis of HCC:

               -  For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of
                  HCC documented by cytology and/or histology.

               -  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).

          3. HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are
             expected to be curative.

          4. 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             treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by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).

          5. Prior systemic treatment was discontinued for at least 2 weeks prior to the Baseline
             Visit.

          6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).

          7. Cirrhosis classified as Child-Pugh Class B (Appendix C).

          8. The following laboratory values must be documented within 3 days prior to the first
             dose of study drug:

               -  Absolute neutrophil count (ANC) ≥ 1.5 × 109/L

               -  Platelet count ≥ 75 × 109/L

               -  Serum creatinine ≤ 2.0 mg/dL

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the
                  upper limit of normal (ULN)

               -  Total bilirubin ≤ 3.0 mg/dL

               -  Serum albumin ≥ 2.8 g/dL

               -  Prothrombin time (PT) no greater than 6 seconds longer than control.

          9. Life expectancy of ≥ 6 weeks.

        Exclusion Criteria:

          1. Receipt of no, or of >1, prior systemic drug therapies for HCC.

          2. 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.

          3. Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved
             to ≤ Grade 1, as determined by CTCAE v 4.0.

          4. Locoregional treatment within 4 weeks prior to the Baseline Visit.

          5. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.

          6. Use of any investigational agent within 4 weeks prior to the Baseline Visit.

          7. Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.

          8. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion
             within 4 weeks prior to the Baseline Visit.

          9. Active bacterial, viral, or fungal infection requiring systemic therapy or operative
             or radiological intervention.

         10. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related
             illness.

         11. Liver transplant.

         12. Active malignancy other than HCC.

         13. Uncontrolled arterial hypertension or congestive heart failure (New York Heart
             Association Classification 3 or 4) (Appendix B).

         14. 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.

         15. 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.

         16. Pregnant or lactating female.

         17. 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.