Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)

Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 2014
End Date:September 2018
Contact:Michael H Silverman, MD

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A Phase 2 Study in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects With Child-Pugh Class B Cirrhosis

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.

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:

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treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by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

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

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.
We found this trial at
Aurora, Colorado 80045
Aurora, CO
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5323 Harry Hines Boulevard
Dallas, Texas 75390
Dallas, TX
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62 ulitsa "Pere Toshev"
Plovdiv, 4004
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