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NCT03037385 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 590
- Enrollment target
NCT03037385 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 590 participants.
The verdict
NCT03037385, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 590 participants
- Enrollment target
Study 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.
Interventions
- DRUG pralsetinib (BLU-667)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 590 participants |
| Start Date | 2017-03-17 |
| Est. Completion | 2024-03-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03037385
The ClinicalTrials.gov registry entry for NCT03037385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 590 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which pralsetinib (BLU-667) is the first listed.
NCT03037385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03037385 about?
NCT03037385 is a clinical study titled "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) administered orally in participants with medullary thyroid cancer (MTC), RET-alter...
What is the current status of trial NCT03037385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 590 participants. The study started on 2017-03-17. Estimated completion is 2024-03-21.
What interventions are being tested in trial NCT03037385?
The interventions under investigation include: pralsetinib (BLU-667) (DRUG).
Who is sponsoring clinical trial NCT03037385?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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