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NCT04739358 · ClinicalTrials.gov registry record · Phase 1
CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC
A Phase 1 study, sponsored by Criterium.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04739358: Clinical Trial Phase 1 study, sponsored by Criterium.
NCT04739358 is a Phase 1 study that was terminated before completion, run by Criterium. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04739358, a Phase 1 study, was terminated before completion, sponsored by Criterium.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer with central nervous system metastasis. In some patients, who have developed resistance to their tyrosine kinase inhibitors (TKIs), this study will look at how effective tepotinib is in combination with TKIs. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life.
Primary Outcome
Dose Escalation Phase: DLT: This is defined as any ≥ to Grade 3 study drug-related toxicity (CTCAE v5.0) occurring within the first cycle of dosing at a given dose level without resolution within 7 days of holding study drug and appropriate supportive care.
Interventions
- DRUG Tepotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2023-06-23 |
| Phase | Phase 1 |
Why NCT04739358 stopped before completion
NCT04739358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Tepotinib is the first listed.
NCT04739358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04739358 about?
NCT04739358 is a clinical study titled "CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC". This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer with central nervous system metastasis. In some patients, who have developed resistance to their tyrosine kinase inhibitors (TKIs), this study will look at how effective tepotinib is ...
What is the current status of trial NCT04739358?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-05-25. Estimated completion is 2023-06-23.
What interventions are being tested in trial NCT04739358?
The interventions under investigation include: Tepotinib (DRUG).
Who is sponsoring clinical trial NCT04739358?
This trial is sponsored by Criterium, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04739358's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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