drugset / Trial / NCT02728492

Safety, Tolerability and Pharmacokinetics of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Chemotherapy

NCT02728492

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Quisinostat besides its own efficacy, which can potentially lead to better results of polychemotherapy and increase the mean time to progression, it may be demonstrated that Quisinostat leads to sustained tumor sensitivity to platinum drugs. In this study safety and tolerability of multiple administrations of Quisinostat in doses ranging from 8 mg to 12 mg combined with standard backbone chemotherapy in patients with non-small cell lung cancer (second line) and ovarian cancer (second and subsequent lines) will be investigated.

Timeline

Start
2013-08
Primary completion
2015-12
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Quisinostat Small molecule 8 mg
Subject Quisinostat Small molecule 10 mg
Subject Quisinostat Small molecule 12 mg
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified 75 mg/m2
Background Gemcitabine Small molecule 1000 mg/m2
Background Gemcitabine Small molecule 1250 mg/m2
Background Paclitaxel Small molecule 175 mg/m2