Sorafenib and LBH589 in Hepatocellular Carcinoma (HCC)
|ClinicalTrials.gov Identifier: NCT00823290|
Recruitment Status : Unknown
Verified January 2009 by University of Erlangen-Nürnberg Medical School.
Recruitment status was: Recruiting
First Posted : January 15, 2009
Last Update Posted : January 12, 2010
Histone deacetylase inhibitors (HDACi) like LBH589 have recently been established as novel potent anti-cancer agents for solid and hematologic malignancies. Several pre-clinical reports have shown a good anti-tumoral activity of different HDACi on human or murine HCC models. These compounds, e.g. Trichostatin A, SAHA, MS-275 and others, have been shown to induce apoptosis in HCC cells and to inhibit growth of HCC by inhibiting proliferation and tumor-related angiogenesis in vivo. Furthermore, HDACi sensitize HCC in a synergistic manner to other forms of cytotoxic stimulation, e.g. by conventional chemotherapeutic drugs or TRAIL-mediated apoptosis. It has also been shown that the combination of HDACi with various kinase inhibitors like sorafenib, erlotinib or others, promotes the anti-tumor efficacy of single agents.
Based on the investigators' own previous experiences with different HDACi and LBH589 in preclinical HCC models, a strong anti-proliferative and pro-apoptotic as well as an anti-angiogenic effect will be expected by combining LBH589 with an existing sorafenib treatment. It is assumed that this combination will prolong overall survival and time-to-progression with lowered adverse effects in HCC patients.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Sorafenib + LBH589||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Sorafenib and LBH589 in the Treatment of Advanced HCC|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
Drug: Sorafenib + LBH589
- Maximum tolerated dose of LBH589 [ Time Frame: 1 year ]
- Safety, tolerability and adverse events (based on CTCAE 3.0) [ Time Frame: 1 year ]
- Reduction of lesion size (radiologically assessed according to RECIST) [ Time Frame: 1 year ]
- Laboratory abnormalities (CTC grade 3 or grade 4 toxicities) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823290
|Contact: Matthias Ocker, MD||+49-6421-58 ext 68931||Matthias.Ocker@staff.uni-marburg.de|
|Contact: Susanne Gahr, MD||+49-9131-85 ext email@example.com|
|Department of Medicine 1, University Hospital Erlangen||Recruiting|
|Erlangen, Germany, 91054|
|Contact: Matthias Ocker, MD +49-6421-58 ext 68931 Matthias.Ocker@staff.uni-marburg.de|
|Contact: Susanne Gahr, MD +49-9131-85 ext 35000 firstname.lastname@example.org|
|Principal Investigator: Deike Strobel, MD|