Spots Global Cancer Trial Database for Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
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Trial Identification
Brief Title: Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Official Title: A Phase II, Open-label, Single-arm Study of Berzosertib (M6620) in Combination With Topotecan in Participants With Relapsed Platinum-resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Study ID: NCT04768296
Conditions
Study Description
Brief Summary: The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Medical Foundation, Santa Rosa, California, United States
St Joseph Heritage Healthcare, Santa Rosa, California, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology, Topeka, Kansas, United States
National Cancer Institute, Bethesda, Maryland, United States
Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
MidAmerica Cancer Care, Kansas City, Missouri, United States
NJ Center for Cancer Research, Brick, New Jersey, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
FirstHealth of the Carolinas, Inc., Pinehurst, North Carolina, United States
Summa Health, Akron, Ohio, United States
Toledo Clinic, Toledo, Ohio, United States
Millennium Physicians Association, LLP, Houston, Texas, United States
Centre Hospitalier de l'Ardenne, Arlon, , Belgium
Institut Jules Bordet - Department of Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
AZ Delta, Roeselare, , Belgium
CHU UCL Namur - Mont-Godinne, Yvoir, , Belgium
Beijing Cancer Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Sichuan Cancer Hospital, Chengdu, , China
West China Hospital, Sichuan University, Chengdu, , China
Jiangsu Province Hospital, Nanjing, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Zhejiang University school of medicine, Zhejiang, , China
Institut Bergonié, Bordeaux cedex, , France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie, Créteil, , France
Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie, Lille, , France
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale, Poitiers, , France
CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie, Saint-Herblain, , France
CHU de Strasbourg - Nouvel Hôpital Civil - Service de Pneumologie, Strasbourg, , France
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST, Meldola, , Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda), Milano, , Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello), Pisa, , Italy
Istituto Nazionale Tumori Regina Elena IRCCS, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica, Rome, , Italy
National Cancer Center Hospital, Chuo-ku, , Japan
Kansai Medical University Hospital, Hirakata-shi, , Japan
National Cancer Center Hospital East, Kashiwa-shi, , Japan
Cancer Institute Hospital of JFCR, Koto-ku, , Japan
Kindai University Hospital, Osaka, , Japan
Kurume University Hospital, Osaka, , Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, , Japan
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria - Oncology Service, Malaga, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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