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Hepatocellular CarcinomaPhase 2ShelterNCT00943449

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

A Phase 2 study testing 4SC-201 and Sorafenib in people with Hepatocellular Carcinoma, run by 4SC AG at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
4SC-201 and Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
15 sitesin 2 countries
Study dates
Jul 2009to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Germany8 sites

  • ONKOPLUS Beratung und Hilfe für Menschen mit Krebs

    Berlin, 14195

  • Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)

    Essen, 45147

  • Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)

    Hamburg, 20246

  • Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)

    Heidelberg, 69120

  • Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)

    Mainz, 55131

  • Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)

    Munich, 81675

  • Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)

    Tübingen, 72076

Other trials in Germany

Italy7 sites

  • l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi

    Bologna, 40138

  • l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)

    Genova, 16132

  • Istituto Europea di Oncologia EIO

    Milan, 20141

  • A.O.R.N. Monaldi-Cotugno-CTO

    Naples, 80131

  • l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV

    Padova

  • l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"

    Palermo, 12990127

  • L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.

    Rozzano-Milano, 20089

Other trials in Italy

About this 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

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.

Being tested
4SC-201, Sorafenib
Keywords
Hepatocellular Carcinoma, Sorafenib, HDAC, 4SC-201, Phase II, Resminostat
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4SC-201Drug

    oral administration

  • SorafenibDrug

    oral administration

Study groups in NCT00943449
Study groupRoleWhat they receive
4SC-201ExperimentalNot described
Receives: Drug: 4SC-201
4SC-201 + SorafenibExperimentalNot described
Receives: Drug: 4SC-201; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201

    Measured: 12 weeks

Secondary outcomes (3)

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

    Measured: 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

    Measured: 12 weeks

  3. To investigate biomarkers

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00943449
Sponsor's protocol ID
4SC-201-1-2009
Acronym
Shelter
Status last verified
Jan 2014
First submitted
21 Jul 2009
Last updated
16 Jan 2014
Results posted
No

Publications

  • Bitzer M, Horger M, Giannini EG, Ganten TM, Worns 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.

    PubMed 26952006

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4SC-201 and Sorafenib in people with Hepatocellular Carcinoma, run by 4SC AG at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00943449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.

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