Summary

Eligibility
for people ages 16 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Invasive Fungal Infections, Anti fungal, Invasive aspergillosis, Rare moulds, Coccidioidomycosis, Infections, Communicable Diseases, Mycoses, Olorofim, Olorofim (F901318)

Eligibility

You can join if…

Open to people ages 16 years and up

  • 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
  • Females 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
  • Participants with invasive fungal disease
  • Participants who have limited alternative treatment options

You CAN'T join if...

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

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Valley Fever Institute at Kern Medical Center
    Bakersfield California 93306 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
F2G Biotech GmbH
Links
Sign up for this study
ID
NCT03583164
Phase
Phase 2 Invasive Fungal Infections Research Study
Study Type
Interventional
Participants
About 203 people participating
Last Updated