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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR PRALSETINIB


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All Clinical Trials for Pralsetinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03037385 ↗ Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Recruiting Blueprint Medicines Corporation Phase 1/Phase 2 2017-03-17 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 patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.
NCT03037385 ↗ Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Recruiting Hoffmann-La Roche Phase 1/Phase 2 2017-03-17 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 patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.
NCT04222972 ↗ A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) Recruiting Blueprint Medicines Corporation Phase 3 2020-07-24 This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.
NCT04222972 ↗ A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) Recruiting Hoffmann-La Roche Phase 3 2020-07-24 This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.
NCT04302025 ↗ A Study of Alectinib, Entrectinib, Vemurafenib Plus Cobimetinib, or Pralsetinib in Patients With Resectable Stages II-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, BRAF V600, or RET Molecular Alterations Recruiting Blueprint Medicines Corporation Phase 2 2020-11-06 This trial will evaluate the efficacy and safety of targeted therapies in participants with resectable Stage IIA, IIB, IIIA, and select IIIB (T3N2) resectable and untreated non-small cell lung cancer (NSCLC) tumors with selected molecular alterations.
NCT04302025 ↗ A Study of Alectinib, Entrectinib, Vemurafenib Plus Cobimetinib, or Pralsetinib in Patients With Resectable Stages II-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, BRAF V600, or RET Molecular Alterations Recruiting Genentech, Inc. Phase 2 2020-11-06 This trial will evaluate the efficacy and safety of targeted therapies in participants with resectable Stage IIA, IIB, IIIA, and select IIIB (T3N2) resectable and untreated non-small cell lung cancer (NSCLC) tumors with selected molecular alterations.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pralsetinib

Condition Name

Condition Name for Pralsetinib
Intervention Trials
Respiratory Tract Neoplasms 2
Neoplasms 2
Neoplasms by Histologic Type 2
Carcinoma 2
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Condition MeSH

Condition MeSH for Pralsetinib
Intervention Trials
Lung Neoplasms 4
Carcinoma, Non-Small-Cell Lung 4
Neoplasms 3
Respiratory Tract Neoplasms 2
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Clinical Trial Locations for Pralsetinib

Trials by Country

Trials by Country for Pralsetinib
Location Trials
United States 94
Spain 15
Italy 15
Australia 11
Brazil 5
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Trials by US State

Trials by US State for Pralsetinib
Location Trials
California 7
Michigan 6
Texas 6
Florida 5
New York 4
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Clinical Trial Progress for Pralsetinib

Clinical Trial Phase

Clinical Trial Phase for Pralsetinib
Clinical Trial Phase Trials
Phase 3 3
Phase 2 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Pralsetinib
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Pralsetinib

Sponsor Name

Sponsor Name for Pralsetinib
Sponsor Trials
Hoffmann-La Roche 5
Blueprint Medicines Corporation 3
Genentech, Inc. 2
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Sponsor Type

Sponsor Type for Pralsetinib
Sponsor Trials
Industry 10
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Serving leading biopharmaceutical companies globally:

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