On May 5th, 2016, IPHARMA was authorized by the Ministry of Healthcare of the Russian Federation to conduct the Phase II clinical study of the medicinal product Quisinostat.
Protocol № ONC-14-NSCLCII-1-1QUI-3 "Multicenter double-blind randomized placebo-controlled Phase II clinical study with the combination of Gemcitabine, Cisplatin and Quisinostat versus Gemcitabine, Cisplatin and placebo in 1st line treatment of patients with advanced Stage IIIb-IV squamous NSCLC".
The study will be conducted at the premises of the leading cancer research centers and dispensaries. A total of 14 centers in 9 cities of Russia will be involved in the study conduct.
The study objective is to compare progression-free survival (PFS) in patients with advanced Stage IIIb-IV squamous non-small-cell lung cancer (NSCLC).
The study is conducted by the NewVac Company (ChemRar High Tec Center group of companies) in association with Janssen (pharmaceutical company of Johnson & Johnson) as part of investigating Quisinostat for the treatment of patients with solid tumors.
IPHARMA has a large experience in conducting studies of innovative oncological drugs in patients with lung cancer, prostate cancer, ovarian cancer, breast cancer, Non-Hodgkin's Lymphoma and other diseases.
In conduct of the study IPHARMA specialists will manage monitoring, data collecting and processing, medical expertise and study report preparation in accordance with international standards.