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
Public ClinicalTrials.gov record NCT03037385. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03037385
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 590 participants
Conditions and interventions
Conditions
- 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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 17, 2017 (Actual)
- Primary completion
- Mar 21, 2024 (Actual)
- Completion
- Mar 21, 2024 (Actual)
- Last update posted
- May 31, 2025
2017 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136-1002 | — |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044-3257 | — |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114-2696 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902-3003 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110-1010 | — |
| Albany Medical Center | Albany | New York | 12208-3412 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705-1165 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4000 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03037385, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 31, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03037385 live on ClinicalTrials.gov.