Clinical trials: Pralsetinib
RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer
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
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)…
- Conditions
- RET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer, RET-altered Papillary Thyroid Cancer, RET-altered Colon Cancer
- Trial name
- ARROW (NCT03037385)
- Testing
- pralsetinib (BLU-667)
- Where
- 71 sites in United States, Belgium and 11 more
- Volunteers
- 590 people
- Sponsor
- Hoffmann-La Roche
Medullary Thyroid Cancer
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).
A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC…
- Trial name
- AcceleRET-MTC (NCT04760288)
- Testing
- Pralsetinib, Cabozantinib, Vandetanib
- Where
- Spain
- Sponsor
- Hoffmann-La Roche
Non-small Cell Lung Cancer, RET Fusion
A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC
This study is a single-arm, multicenter real-world clinical study designed to evaluate the safety and efficacy of Leucogen (a leukocyte-increasing agent) as a prophylactic treatment in patients with RET fusion-positive non-small…
- Conditions
- Non-small Cell Lung Cancer, RET Fusion, Pralsetinib
- Trial name
- NCT07418879
- Testing
- Pralsetinib, Leucogen
- Volunteers
- 25 people
- Sponsor
- Fudan University
Medullary Thyroid Cancer (MTC)
A Prospective Cohort Study of Pralsetinib or Anlotinib in the Treatment of Locally Advanced and/or Metastatic Medullary Thyroid Carcinoma With RET Gene Mutations
This trial is a prospective, observational Phase II clinical study. For patients with locally advanced and/or metastatic medullary thyroid carcinoma with RET gene mutations who require systemic treatment, they are randomly…
- Trial name
- NCT07048964
- Volunteers
- 40 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
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…
- Conditions
- RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms
- Trial name
- AcceleRET-Lung (NCT04222972)
- Testing
- Pralsetinib, Carboplatin, Cisplatin
- Where
- 74 sites in Argentina, Australia and 20 more
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
NSCLC (Non-small Cell Lung Cancer), Thyroid Cancer
Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors
An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with…
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Thyroid Cancer, Solid Tumor Malignancies, Advanced Malignancies
- Trial name
- NCT07704658
- Testing
- Pralsetinib, CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive
- Where
- 2 sites in Spain
- Volunteers
- 12 people
- Sponsor
- Rigel Pharmaceuticals
Non-Small Cell Lung Cancer, Medullary Thyroid Cancer
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
This is a global, multicenter, open-label pre-approval access program to provide access to pralsetinib (BLU-667) until such time that pralsetinib becomes available through other mechanisms or the Sponsor chooses to discontinue…
- Trial name
- NCT04204928
- Testing
- pralsetinib (BLU-667)
- Sponsor
- Blueprint Medicines Corporation
RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm
External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
This is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with RET-fusion positive advanced NSCLC.
- Conditions
- RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms
- Trial name
- NCT04697446
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 279 people
- Sponsor
- Blueprint Medicines Corporation