Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options

clipboard-pencil

About the study

A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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
  2. Ability and willingness to comply with the protocol.
  3. Able to take oral medication
  4. Females must be non-lactating and at no risk of pregnancy
  5. Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
  6. Participants with invasive fungal disease
  7. Participants who have limited alternative treatment options

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Women who are pregnant or breastfeeding.
  2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
  3. Participants with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
  4. Human Immunodeficiency Virus (HIV) infection but not currently receiving antiretroviral therapy.
  5. Participants with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the participant
  6. Previously enrolled participants or participants enrolled in any clinical trial within the last 30 days
  7. Participants receiving treatment limited to supportive care due to predicted short survival time.
  8. Prohibited concomitant medications.
  9. * Any exclusion criteria required by local regulatory authorities.


pin location

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.
Phone iconCall 43 664 3582281Email iconEmail Study Center

Study Details


Contition
Invasive Fungal Infections
Age (in years)
16+
Phase
PHASE2
Participants Needed
203
Est. Completion Date
Feb 10, 2023
Treatment Type
INTERVENTIONAL

Sponsor
F2G Biotech GmbH
ClinicalTrials.gov NCT Identifier
NCT03583164
Study Number
F9013180032

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?