Spots Global Cancer Trial Database for Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
Official Title: A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer
Study ID: NCT02093962
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.
Detailed Description: TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Pemetrexed has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. There is evidence supporting the presence of hypoxia in NSCLC lesions based on a hypoxia PET study. Combining pemetrexed with TH-302 may enable the targeting of both the normoxic and hypoxic regions of NSCLC lesions.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Cancer Center, Birmingham, Alabama, United States
Ironwood Cancer and Research Centers, Chandler, Arizona, United States
California Cancer Center, Encinitas, California, United States
California Cancer Center Associates, Fresno, California, United States
UCLA-Department of Medicine a Division of Hem/Onc, Los Angeles, California, United States
Sarcoma Oncology Research Center, Santa Monica, California, United States
VA Eastern Colorado Healthcare System, Denver, Colorado, United States
Christiana Care Health Services, Newark, Delaware, United States
Cancer Specialists of North Florida - CBO, Jacksonville Beach, Florida, United States
AMPM Research, Miami, Florida, United States
Research Medical Center, Kansas City, Kansas, United States
Ochsner Clinical Foundation, New Orleans, Louisiana, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
St. Joseph Mercy Ann Arbor Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Montefire-Einstein Center for Cancer Care, Bronx, New York, United States
Clinical Research Alliance, New York, New York, United States
Durham VA Medical Center, Durham, North Carolina, United States
W.G. (Bill) Hefner VA Medical Center, Salisbury, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
DORN VA Medical Center, Columbia, South Carolina, United States
Regional Cancer Care Institute at Regional Health, Rapid City, South Dakota, United States
Associates in Oncology & Hematology, Chattanooga, Tennessee, United States
San Antonio Military Medical Center, Fort Sam Houston, Texas, United States
Oncology Consultants, Houston, Texas, United States
Millennium Oncology, Houston, Texas, United States
Fpr Belvoir Community Hospital, Fort Belvoir, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Hospital Na Bulovce, Department of Pneumology and Thoracic Surgery, Liben, , Czechia
General Univesity Hospital in Prague, Clinic of Oncology, Prague, , Czechia
Thomayer Hospital, Clinic of Pneumology, Praha 4, , Czechia
Regional Hospital T. Bta, Department of Pneumology, Zlin, , Czechia
Asklepios Fachkliniken Munchen-Gaunting, Gauting, Bavaria, Germany
Marien Hospital Herne, Herne, North Rhine-Westphalia, Germany
Charité Universitätsmedizin Berlin;, Berlin, , Germany
Klinikum Frankfurt Höchst GmbH, Frankfurt, , Germany
Lungen Clinic Grosshandsdorf GmbH, Grosshansdorf, , Germany
Universitatsklinikum Schleswig-Holstein, Lubeck, , Germany
Städtisches Klinikum München - Klinikum Bogenhausen, München, , Germany
Universitätsklinikum Ulm; Zentrum für Innere Medizin, Ulm, , Germany
IASO General, Oncology Unit, Athens, , Greece
Attikon University General Hospital, Athens, , Greece
Department of Medical Oncology, Heraklion, , Greece
University General Hospital of Patras, Oncology Unit, Patras, , Greece
Koranyi National Institute of TBC and Pulmonology, 14th Dept of Pulmonology, Budapest, , Hungary
Koranyi National Institute of TBC and Pulmonology, 6th Department of Pulmonology, Budapest, , Hungary
Koranyi National Institute of TBC and Pulmonology, 8th Department of Pulmonology, Budapest, , Hungary
University of Debrecen, Medical and Health Science Center, Department of Pulmonology, Debrecen, , Hungary
Csongrad County Hospital of Chest Diseases, Deszk, , Hungary
Hetenyi Geza Hospital, Department of Oncology, Szolnok, , Hungary
"Mater Salutis" Hospital - Operative Unit of Oncology, Verona, Legnago, Italy
A.O.U.S. Luigi GonzagaUniversity Hospital, Orbassano, Torino, Italy
Hospital Bellaria "Carlo Alberto Pizzardi" - Operative Unit of Oncology, Bologna, , Italy
IRCCS Azienda Ospedallera Universitaria San Martino-IST-Istituto Nazionale per la Ricerca sul Cancro, Genova, , Italy
European Institute of Oncology (IEO) - Medical Care Unit, Milan, , Italy
S. Gerardo Hospital - Complex Structure of Medical Oncology, Monza, , Italy
Azienda Ospedaliera Universitaria Policlinico della Seconda Universita di Napoli, Napoli, , Italy
University Hospital of Pisa, Department of Cardothoracic Surgery, Operative unit of Pneumology, Pisa, , Italy
"Santa Maria degli Angeli" - Hospital - Complex Operative Unit of Oncology, Pordenone, , Italy
San Camillo-Forlanini Hospital - U.O.C. Pneumologia Oncologica 1, Rome, , Italy
Med-Polonia Sp. z o.o., Poznan, , Poland
L. Rydygier Provencial Hospitals in Torun, Dept. of Tumors Chemotherapy, Torun, , Poland
Maria Sklodowska-Curie Institute of Oncology in Warsaw, Warsaw, , Poland
Oncology Centre "Sf. Nectarie", Craiova, Dolj County, Romania
Pro. Dr. Alex Trestioreanu Institute of Oncology, Bucharest, , Romania
Prof. Dr. Ioan Chiricuta Institute of Oncology, Cluj-Napoca, , Romania
Republican Clinical Oncology Center under the Ministry of Healthcare of Tatarstan Republic, Kazan, Republic Of Tatarstan, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of Medical Sciences, Moscow, , Russian Federation
Blokhin Russian Oncology Research Center, Moscow, , Russian Federation
State Healthcare Institution: Nizhny Novgorod Regional Oncology Center, Nizhny Novgorod, , Russian Federation
St. Petersburg Clinical Center for Applied Special Medical Services (Oncology), St. Petersburg, , Russian Federation
St. Petersburg 1st State Medical University n.a.I.P. Pavlov under the Ministry of Healthcare of the Russian Federation, St. Petersburg, , Russian Federation
City Clinical Oncology Center, Oncology Department (Thoracic Oncology), St. Petersburg, , Russian Federation
General University Hospital Gregorio Maranon, Dept. of Oncology, Madrid, , Spain
Jimenez Diaz Foundation, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
University Hospital Virgen de Valme, Sevilla, , Spain
Dr. Peset University Hospital, Dept. of Oncology, Valencia, , Spain
Hospital Universitario La Fe, Servicio de Oncologia, Valencia, , Spain
Contact Details
Name: Tillman Pearce, MD
Affiliation: Threshold Pharmaceuticals
Role: STUDY_CHAIR
Name: Jonathan Goldman, MD
Affiliation: UCLA-Dept of Medicine a Div of Hem/Onc
Role: PRINCIPAL_INVESTIGATOR
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