The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer
Official Title: A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of Chemotherapy
Study ID: NCT01380769
Brief Summary: The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).
Detailed Description: Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
State Medical Institution Republican Oncology Center, Saransk, Republic Of Mordovia, Russian Federation
State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic, Kazan, Republic Of Tatarstan, Russian Federation
Arkhangelsk Regional Clinical Oncology Center, Arkhangelsk, , Russian Federation
State Healthcare Institution: Bryansk Regional Oncology Center, Bryansk, , Russian Federation
Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, , Russian Federation
Kursk Regional Oncology Center, Kursk, , Russian Federation
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center, Moscow, , Russian Federation
Non-Government Medical Institution: Central Clinical Hospital #2, Moscow, , Russian Federation
State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center, Nizhny Novgorod, , Russian Federation
City Clinical Hospital #1, Novosibirsk, , Russian Federation
State Medical Institution: Pyatigorsk Oncological Center, Pyatigorsk, , Russian Federation
St. Petersburg Medical University, St. Petersburg, , Russian Federation
City Clinical Oncology Center, St. Petersburg, , Russian Federation
Stavropol Regional Clinical Oncology Center, Stavropol, , Russian Federation
Tambov Regional Oncology Center, Tambov, , Russian Federation
Primorsky Regional Oncology Center, Vladivostok, , Russian Federation
Regional Clinical Oncology Center, Yaroslavl, , Russian Federation
Dnipropetrovsk State Medical Academy, Dnipropetrovsk, , Ukraine
Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center, Donetsk, , Ukraine
Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility, Ivano-Frankivsk, , Ukraine
Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Khmelnytskyi Regional Oncology Center, Khmelnytsky, , Ukraine
Kyiv City Oncology Hospital, Kyiv, , Ukraine
Sumy Regional Clinical Oncology Center, Sumy, , Ukraine
Zakarpattia Regional Clinical Oncology Center, Uzhgorod, , Ukraine
Name: NewLink Genetics
Affiliation: NewLink Genetics Inc
Role: STUDY_CHAIR