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Spots Global Cancer Trial Database for A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: NewLink Genetics

Affiliation: NewLink Genetics Inc

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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