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
Completed · Phase 1/Phase 2
Conditions studied: RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer, RET-altered Papillary Thyroid Cancer, RET-altered Colon Cancer, RET-altered Solid Tumors, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Thyroid Diseases, Thyroid Neoplasm, Thyroid Cancer, Papillary, Carcinoma, Neuroendocrine, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Disease, Carcinoma, Bronchogenic, Bronchial Neoplasms, Endocrine System Diseases, Endocrine Gland Neoplasm, Head and Neck Neoplasms, Adenocarcinoma, Papillary, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neuroendocrine Tumors, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue, Colonic Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasm, Digestive System Disease, Gastrointestinal Disease, Colonic Diseases, Intestinal Disease
In brief
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.
Key facts
- Study ID
- NCT03037385
- Run by
- Hoffmann-La Roche
- People needed
- 590
- Starts
- 2017-03-17
- Expected to finish
- 2024-03-21
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UC Irvine Medical Center — Orange, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
- Sylvester Comprehensive Cancer Center — 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 — St 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
- 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
- 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, China
- Mayo Clinic Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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