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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943449
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : January 16, 2014
Information provided by:

July 21, 2009
July 22, 2009
January 16, 2014
July 2009
June 2012   (Final data collection date for primary outcome measure)
Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201 [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00943449 on Archive Site
  • To establish the MTD of 4SC-201 in combination with Sorafenib [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • To investigate biomarkers [ Time Frame: 12 weeks ]
Same as current
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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
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: 4SC-201
    oral administration
  • Drug: Sorafenib
    oral administration
  • Experimental: 4SC-201
    Intervention: Drug: 4SC-201
  • Experimental: 4SC-201 + Sorafenib
    • Drug: 4SC-201
    • Drug: Sorafenib
Bitzer M, Horger M, Giannini EG, Ganten TM, Wörns MA, Siveke JT, Dollinger MM, Gerken G, Scheulen ME, Wege H, Zagonel V, Cillo U, Trevisani F, Santoro A, Montesarchio V, Malek NP, Holzapfel J, Herz T, Ammendola AS, Pegoraro S, Hauns B, Mais A, Lauer UM, Henning SW, Hentsch B. Resminostat plus sorafenib as second-line therapy of advanced hepatocellular carcinoma - The SHELTER study. J Hepatol. 2016 Aug;65(2):280-8. doi: 10.1016/j.jhep.2016.02.043. Epub 2016 Mar 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2013
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy
Not Provided
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Principal Investigator: Michael Bitzer, Prof. MD Medizinische Universitäts-Klinik Tübingen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP