4SC-201 and Sorafenib in Advanced Hepatocellular Carcinoma - Full Text View

Sponsor:	4SC AG
Information provided by:	4SC AG
ClinicalTrials.gov Identifier:	NCT00943449

Purpose

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.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Drug: 4SC-201 Drug: Sorafenib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by 4SC AG:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To establish the MTD of 4SC-201 in combination with Sorafenib [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
To investigate biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
4SC-201: Experimental	Drug: 4SC-201 oral administration
4SC-201 + Sorafenib: Experimental	Drug: 4SC-201 oral administration Drug: Sorafenib oral administration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943449

Contacts

Contact: Bernhard Hauns, MD

+49-89-700763-0

Bernhard.Hauns@4sc.com

Locations

Germany
Medizinische Universitäts-Klinik	Recruiting
Tübingen, Germany
Klinikum rechts der Isar	Recruiting
Munich, Germany
Johannes Gutenberg Universität	Recruiting
Mainz, Germany
Medizinische Universitäts-Klinik	Recruiting
Heidelberg, Germany
Universitätsklinikum	Recruiting
Halle, Germany

Sponsors and Collaborators

4SC AG

Investigators

Principal Investigator:

Michael Bitzer, Prof. MD

Medizinische Universitäts-Klinik Tübingen

More Information

No publications provided

Study ID Numbers:	4SC-201-1-2009
Study First Received:	July 21, 2009
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00943449 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 4SC AG:

Hepatocellular Carcinoma
Sorafenib
HDAC
4SC-201
Phase II

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010