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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00943449

Acronym

Shelter

Enrollment

Registered

2009-07-22

Start date

2009-07-31

Completion date

2013-09-30

Last updated

2014-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Sorafenib, HDAC, 4SC-201, Phase II, Resminostat

Brief summary

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.

Interventions

DRUG4SC-201

oral administration

DRUGSorafenib

oral administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 establish the MTD of 4SC-201 in combination with Sorafenib	12 weeks
To investigate biomarkers	12 weeks

Countries

Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026