Spots Global Cancer Trial Database for Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
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Trial Identification
Brief Title: Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
Official Title: A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
Study ID: NCT03037385
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
Detailed Description: The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll participants with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or the participants must be intolerant to or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital, Phoenix, Arizona, United States
UC Irvine Medical Center, Orange, California, United States
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center; University of Miami School of Medicine, Miami, Florida, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
Massachusetts General Hospital., Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
Albany Medical Center, Albany, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital, New York, New York, United States
Oregon Health & Science University, Portland, Oregon, United States
Stellar - Chance Laboratories, Philadelphia, Pennsylvania, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Antwerp University Hospital, Edegem, , Belgium
Beijing Cancer Hospital, Beijing, , China
The affiliated Cancer Hospital, School of Medicine, UESTC, Chengdu, , China
West China Hospital, Sichuan University, Chengdu, , China
Chongqing Cancer Hospital, Chongqing, , China
Fujian Provincial Cancer Hospital, Fuzhou City, , China
First Affiliated Hospital of Gannan Medical University, Ganzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Guangdong General Hospital, Guangzhou, , China
Zhejiang Provincial People?s Hospital, Hangzhou, , China
Jinan Central Hospital, Jinan City, , China
Gansu Cancer Hospital, Lanzhou, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Henan Cancer Hospital, Zhengzhou, , China
Institut Bergonie, Bordeaux, , France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille, , France
Centre Léon Bérard, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
CHU de Rennes - Hopital de Pontchaillo, Rennes, , France
Hôpital Larrey;Université Paul Sabatier, Toulouse, , France
Gustave Roussy, Villejuif, , France
Helios Klinikum Emil von Behring GmbH, Berlin, , Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung, Essen, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Klinikum der Universität München, Muenchen, , Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie, Oldenburg, , Germany
The Chinese University of Hong Kong, Shatin, , Hong Kong
Ospedale Santa Maria Delle Croci, Ravenna, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena, Roma, Lazio, Italy
IEO; Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda, Milano, Lombardia, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System; Oncology, Seoul, , Korea, Republic of
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
National Cancer Centre, Singapore, , Singapore
Institut Catala d Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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