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A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Clinical Phase I / II Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

Clinical Trial Summary

The Belinostat-Erlotinib trial is designed as an open, non randomized phase I / II trial to assess the efficacy and safety of Belinostat in combination with Erlotinib in patients with non-small cell lung cancer who are eligible for treatment with erlotinib.

Clinical Trial Description

Belinostat, developed by CuraGen, belongs to a new class of hydroxymat-type histone deacetylase (HDAC) inhibitors. HDAC inhibitors, including Belinostat, has shown marked in vitro and in vivo activity against a number of solid tumors and hematological cancers. Belinostat has proven to be effective as a single agent or in combination with other anticancer agents such as doxorubcin, paclitaxel, carboplatin, fluorouracil, bortezumib, and there has been observed synergy between Belinostat or other HDAC inhibitors and EGFR inhibitors gefinitinib and erlonitib. Furthermore, the antineoplastic activity of Belinostat seen in preclinical experiments have resulted in only moderate toxicity. In the two Phase I trials of Belinostat for solid tumors and hematological malignancies Belinostat have been well tolerated at doses up to 2000 mg daily in more than 100 patients. Fatigue, nausea and vomiting has been the main side effects and with none or very mild hematologic toxicity. Approximately 25% of patients in the study of solid tumors achieved stable disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01188707
Study type Interventional
Source Herlev Hospital
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date October 1, 2010
Completion date June 30, 2011
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