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NCT03583164 · ClinicalTrials.gov registry record · Phase 2
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
A Phase 2 study, sponsored by F2G Biotech.
- Completed
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
NCT03583164: Completed Phase 2 study, sponsored by F2G Biotech.
NCT03583164 is a Phase 2 study that has completed, run by F2G Biotech. The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03583164, a Phase 2 study, has completed, sponsored by F2G Biotech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
Study Summary
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
Primary Outcome
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were ass
Interventions
- DRUG Olorofim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2018-06-06 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 2 |
What the finished NCT03583164 record still lists
NCT03583164 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 1 intervention - of which Olorofim is the first listed.
NCT03583164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03583164 about?
NCT03583164 is a clinical study titled "Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options". A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
What is the current status of trial NCT03583164?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2018-06-06. Estimated completion is 2023-02-10.
What interventions are being tested in trial NCT03583164?
The interventions under investigation include: Olorofim (DRUG).
Who is sponsoring clinical trial NCT03583164?
This trial is sponsored by F2G Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03583164's enrollment target sits among peer trials
203 301st of 2000 higher than 1,700 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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