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
- C22.0Liver cell carcinoma
- Registration Number
- DRKS00000376
- Lead Sponsor
- 4SC AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 57
Advanced stage hepatocellular carcinoma.
- 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.
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, except for 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method