Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
About the study
A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Invasive Fungal Infections
Age (in years)
16+
Phase
Phase 2
Participants needed
200
Est. Completion Date
Apr 30, 2023
Treatment type
Interventional
Sponsor
F2G Biotech GmbH
ClinicalTrials.gov identifier
NCT03583164
Study number
F9013180032
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