Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
Purpose
A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
Condition
- Invasive Fungal Infections
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent - Ability and willingness to comply with the protocol. - Able to take oral medication - Female must be non-lactating and at no risk of pregnancy - Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception - Patients with invasive fungal disease - Patients who have limited alternative treatment options
Exclusion Criteria
- Women who are pregnant or breastfeeding. - Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug. - Patients with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis. - HIV infection but not currently receiving antiretroviral therapy. - Patients with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the patient - Previously enrolled patients or patients enrolled in any clinical trial within the last 30 days - Patients receiving treatment limited to supportive care due to predicted short survival time. - Prohibited concomitant medications. - Any exclusion criteria required by local regulatory authorities.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental F901318 |
open-label single-arm of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- F2G Biotech GmbH
Detailed Description
This is the first study in patients of F901318. Patients with a limited treatment options will be enrolled and treated with F901318 (olorofim) for up to 12 weeks.