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Completed

NCT Number: NCT00943449

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ONKOPLUS Beratung und Hilfe für Menschen mit Krebs, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4SC-201

Drug

oral administration

Sorafenib

Drug

oral administration

Primary outcomes

  1. 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

Secondary outcomes

  1. To establish the MTD of 4SC-201 in combination with Sorafenib

    Time frame: 12 weeks

  2. 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

  3. To investigate biomarkers

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

4SC AG

Industry

Registry information

Official study title

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

Acronym: Shelter

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jul 22, 2009
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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