pralsetinib: Clinical Trials

16 trials of pralsetinib, newest first

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6 recruiting, 2 active not recruiting, 2 completed, 2 not yet recruiting. 7 Phase 2, 3 Phase 4, 2 Phase 3, 1 Not applicable, 1 Phase 1.

By phase and status

PhaseTrialsStatus
Phase 27Recruiting 3, Completed 2, Active not recruiting 1, Unknown 1
Phase 43Recruiting 2, Not yet recruiting 1
Phase 32Terminated 1, Withdrawn 1
Not applicable1Not yet recruiting 1
Phase 11Completed 1

Follow pralsetinib: new trials by email Literature Review of pralsetinib trials Research Report on pralsetinib

Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors
Pralsetinib, CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive - NSCLC (Non-small Cell Lung Cancer), Thyroid Cancer
Phase 4RecruitingRigel Pharmaceuticals122026-03-042026-08-10
A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC
Pralsetinib, Leucogen - Non-small Cell Lung Cancer, RET Fusion
Not applicableNot yet recruitingFudan University252026-02-052026-02-18
Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer
Multitarget Tyrosine Kinase Inhibitors, BRAF inhibitor dabrafenib and MEK inhibitor trametinib, RET Inhibitor - Thyroid Cancer, Thyroid Neoplasms
RecruitingFujian Medical University1202025-12-232026-02-19
Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
Dabrafenib, Trametinib, Selpercatinib - Thyroid Neoplasms
Phase 4Not yet recruitingFujian Medical University3352025-07-012025-06-08
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Sunvozertinib, Crizotinib, Pralsetinib - Lung Cancer Stage III, Mutation
Phase 2RecruitingSun Yat-sen University1202024-11-012026-04-21
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).
Pralsetinib, Cabozantinib, Vandetanib - Medullary Thyroid Cancer
Phase 3WithdrawnHoffmann-La Roche2023-11-302024-01-05
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Alectinib, Atezolizumab, Erlotinib - Solid Tumor, Advanced Solid Tumor
Active not recruitingSeoul National University Bundang Hospital10002022-09-282026-09-30
Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer
Anlotinib, Lenvatinib, Sorafenib - Locally Advanced Thyroid Gland Carcinoma
Phase 2RecruitingWest China Hospital752021-06-012024-12-05
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Entrectinib, Alectinib, Atezolizumab - Solid Tumors
Phase 2Active not recruitingHoffmann-La Roche9202021-01-182026-09-04
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Entrectinib, Inavolisib, Alectinib - Advanced Unresectable or Metastatic Solid Malignancy
Phase 2CompletedGenentech, Inc.2522021-01-132025-01-08
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
Alectinib, Entrectinib, Vemurafenib - Non-small Cell Lung Cancer
Phase 2RecruitingGenentech, Inc.992020-11-062026-10-13
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
Erlotinib, Trastuzumab, Trastuzumab emtansine - Breast Cancer, Gastrointestinal Cancer
Phase 2UnknownFondazione per la Medicina Personalizzata4002020-10-072023-10-03
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Pralsetinib, Carboplatin, Cisplatin - RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm
Phase 3TerminatedHoffmann-La Roche2232020-07-242026-03-05
A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
dabrafenib plus trametinib with or without PD-1 antibody, entrectinib or larotrectinib with or without anti-PD-1 antibdoy, pralsetinib or selpercatinib with or without anti-PD-1 antibdoy - Advanced Thyroid Cancer Patients Who Received Target Therapy
Phase 4RecruitingFudan University8002020-01-012025-08-14
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
pralsetinib (BLU-667) - RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer
Phase 1 / Phase 2CompletedHoffmann-La Roche5902017-03-172025-05-31
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
pralsetinib (BLU-667) - Non-Small Cell Lung Cancer, Medullary Thyroid Cancer
Approved for marketingBlueprint Medicines Corporation2021-08-13

Conditions studied

Carcinoma, Non-Small-Cell Lung (8)  ·  Thyroid Neoplasms (4)  ·  Carcinoma, Medullary (3)  ·  Lung Neoplasms (3)  ·  Neoplasms (3)  ·  Adenocarcinoma (2)  ·  Carcinoma (2)  ·  Carcinoma, Bronchogenic (2)  ·  Gastrointestinal Neoplasms (2)  ·  Head and Neck Neoplasms (2)  ·  Lung Diseases (2)  ·  Neoplasms by Histologic Type (2)  ·  Neoplasms by Site (2)  ·  Neoplasms, Germ Cell and Embryonal (2)  ·  Neoplasms, Nerve Tissue (2)

Sponsors

Hoffmann-La Roche (4)  ·  Fudan University (2)  ·  Fujian Medical University (2)  ·  Genentech, Inc. (2)  ·  Blueprint Medicines Corporation (1)  ·  Fondazione per la Medicina Personalizzata (1)  ·  Rigel Pharmaceuticals (1)  ·  Seoul National University Bundang Hospital (1)  ·  Sun Yat-sen University (1)  ·  West China Hospital (1)

Countries

China (7)  ·  Spain (5)  ·  Italy (4)  ·  South Korea (4)  ·  United States (4)  ·  Belgium (3)  ·  France (3)  ·  Germany (3)  ·  United Kingdom (3)  ·  Australia (2)  ·  Brazil (2)  ·  Hong Kong (2)  ·  Japan (2)  ·  Netherlands (2)  ·  Poland (2)

Top investigators

Andrea Botticelli (1)  ·  Dongmei Ji, M.D (1)  ·  Paolo Marchetti (1)  ·  Qinghai Ji, M.D (1)  ·  Si-Yu Wang, MD (1)  ·  Yansong Lin, M.D (1)  ·  Yu Wang, M.D (1)  ·  Zhihui Li, Professor (1)

Results publications

PMID 34118197, PMID 34118198, PMID 35715405, PMID 35962206, PMID 37282666, PMID 37916501, PMID 37934000, PMID 38009200, PMID 38724991, PMID 40086048, PMID 40304938, PMID 40639400, PMID 41023484, PMID 41213248, PMID 41392942, PMID 41886723, PMID 41963505

NIH funding

2023 (2), 2016 (1), 2018 (1), 2019 (1)