Trials / Completed
CompletedNCT03583164
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- F2G Biotech GmbH · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
Detailed description
An open label, single arm Phase IIb study of olorofim (F901318) in participants with invasive fungal infections with limited treatment options. Participants received study treatment for up to 12 weeks in the main phase of the study. At the Investigator's request and after discussion with the medical monitor, open-label treatment with F901318 could be continued in patients judged by the Investigator to need therapy beyond 84 days and considered likely to continue to benefit from extended treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olorofim | 30mg oral tablets |
Timeline
- Start date
- 2018-06-06
- Primary completion
- 2023-02-10
- Completion
- 2023-02-10
- First posted
- 2018-07-11
- Last updated
- 2024-07-10
- Results posted
- 2024-07-10
Locations
82 sites across 17 countries: United States, Australia, Belgium, Brazil, Egypt, France, Germany, Israel, Netherlands, Poland, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03583164. Inclusion in this directory is not an endorsement.