Summary

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

Description

Summary

A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients 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

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.

Keywords

Invasive Fungal Infections Anti fungal Invasive aspergillosis Rare moulds Infections Communicable Diseases Mycoses Olorofim

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
  • 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

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.
  • 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.

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
F2G Biotech GmbH
Links
Sign up for this study
ID
NCT03583164
Phase
Phase 2
Study Type
Interventional
Last Updated