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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

NCT03037385 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2025-05-31

Study results available
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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.

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

Interventions

DRUG

pralsetinib (BLU-667)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-17
Primary Completion
2024-03-21
Completion
2024-03-21
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03037385 on ClinicalTrials.gov