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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03037385 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 590 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (883% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD was defined as the highest tolerated dose of pralsetinib without causing dose limiting toxicities (DLTs). DLT was defined as any Grade ≥3 adverse event (AE) occurring during Cycle 1 during Phase 1 (dose escalation) that is not clearly caused by something other than pralsetinib. RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase.
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 |
What the finished NCT03037385 record still lists
NCT03037385 is an interventional study that assigns participants to a tested intervention. The registered 590 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (883% higher).
The record links to 0 conditions, and to 1 intervention - of which pralsetinib (BLU-667) is the first listed.
NCT03037385 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03037385's enrollment target sits among peer trials
590 31st of 2000 higher than 1,969 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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