4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.

Official Title
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A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: 4SC-201
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Advanced stage hepatocellular carcinoma Patients exhibiting progressive disease under Sorafenib treatment Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included ECOG performance status 0, 1 or 2 Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks Main Exclusion Criteria: Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) - any cancer curatively treated > 3 years prior to entry is permitted Renal failure requiring hemo- or peritoneal dialysis Known central nervous system (CNS) tumors including symptomatic brain metastasis Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I Pregnant or breastfeeding women Sorafenib intolerance Major surgery within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4SC-201<br> | Drug: 4SC-201<br>* oral administration<br>|
| Experimental: 4SC-201 + Sorafenib<br> | Drug: 4SC-201<br>* oral administration<br>Drug: Sorafenib<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the MTD of 4SC-201 in combination with Sorafenib |  | 12 weeks | 
| To investigate the safety and tolerability of repeated oral doses of 4SC-201 and of the treatment combination of ascending repeated oral doses of 4SC-201 and Sorafenib |  | 12 weeks | 
| To investigate biomarkers |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Sorafenib, HDAC, 4SC-201, Phase II, Resminostat