CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 590 enrolled
Drug / intervention
pralsetinib (BLU-667)drug
Likely dose
pralsetinib (BLU-667) — doses >120 mg per day studied in Phase 1; specific Phase 2 dose not specified in criteriaAI-extracted
Key inclusion· 9
  • ✓RET-altered advanced solid tumor (Phase 1 doses >120 mg/day) or RET fusion/mutation confirmed by local/central testing (Phase 2)
  • ✓Group 1 (NSCLC RET fusion): Prior platinum-based chemotherapy required
  • ✓Group 2 (NSCLC RET fusion): No prior platinum chemotherapy, or neoadjuvant/adjuvant platinum >4 months prior
  • ✓Group 3 (MTC): Prior cabozantinib and/or vandetanib required; progression within 14 months
Key exclusion· 9
  • ✕Known primary driver alteration other than RET (e.g., EGFR, ALK, ROS1, BRAF mutations in NSCLC; KRAS, NRAS, BRAF in colorectal)
  • ✕QTcF >470 msec or history of prolonged QT syndrome, Torsades de pointes, or familial prolonged QT
  • ✕Clinically significant uncontrolled cardiovascular disease
  • ✕CNS metastases or primary CNS tumor with progressive neurological symptoms

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03037385
NCT03037385Phase 2Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Jan 31, 2017·Updated May 31, 2025

In Brief

A Phase 2 clinical trial evaluating pralsetinib (BLU-667) for RET-altered Non Small Cell Lung Cancer and 39 related conditions. Completed, enrolled 590 participants across 71 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRET-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
CountriesBelgium, China, France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartMar 17, 2017
Primary CompletionMar 21, 2024
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 9.4 years ago

Interventions

pralsetinib (BLU-667)drug

pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants