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.
«IPHARMA» LLC – an accredited partner of the «Skolkovo» Technopark, Contract Research Organization (CRO), specialized in conducting clinical trials of innovative medicinal products of Russian and foreign developers.
The main competence of the company is the effective and rational organization of clinical trials according to international standards as well as the drug registration support in Russia. IPHARMA team consists of the qualified specialists with an extensive experience in international and local clinical trials. The company has a large scientific background, its own medical expertise and an ability to involve top Russian and foreign specialists.