Phase 2
Completed N=203
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
Source: ClinicalTrials.gov NCT03583164 ↗Enrolled (actual)
203
Serious AEs
65.0%
Results posted
Jul 2024
Primary outcomePrimary: Data Review Committee (DRC) Adjudicated Overall Response at Day 42 — 28.7 Response rate percentage
Summary
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Data Review Committee (DRC) Adjudicated Overall Response at Day 42 |
28.7 | — |
| SECONDARY DRC Adjudicated Overall Response at Day 42 for All Aspergillus |
34.7 | — |
| SECONDARY DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans |
42.3 | — |
| SECONDARY DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species |
36.4 | — |
| SECONDARY DRC Adjudicated Overall Response at Day 42 for Coccidioides Species |
0.0 | — |
| SECONDARY DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi |
33.3 | — |
| SECONDARY DRC Adjudicated Overall Response at Day 84 |
27.2 | — |
| SECONDARY Investigator Assessed Overall Response at Day 42 |
24.8 | — |
| SECONDARY Investigator Assessed Overall Response at Day 84 |
29.7 | — |
| SECONDARY DRC Adjudicated Clinical Response at Day 42 |
59.9 | — |
| SECONDARY DRC Adjudicated Clinical Response at Day 84 |
54.0 | — |
| SECONDARY Investigator Assessed Clinical Response at Day 42 |
53.5 | — |
| SECONDARY Investigator Assessed Clinical Response at Day 84 |
56.4 | — |
| SECONDARY DRC Adjudicated Mycological Response at Day 42 |
18.3 | — |
| SECONDARY DRC Adjudicated Mycological Response at Day 84 |
22.5 | — |
| SECONDARY Investigator Assessed Mycological Response at Day 42 |
25.7 | — |
| SECONDARY Investigator Assessed Mycological Response at Day 84 |
31.7 | — |
| SECONDARY DRC Adjudicated Radiological Response at Day 42 |
11; 10; 12; 55; 6; 7 | — |
| SECONDARY DRC Adjudicated Radiological Response at Day 84 |
14; 11; 5; 36; 6; 5 | — |
| SECONDARY Investigator Assessed Radiological Response at Day 42 |
10; 20; 20; 29; 11; 3 | — |
| SECONDARY Investigator Assessed Radiological Response at Day 84 |
23; 16; 16; 26; 10; 4 | — |
| SECONDARY All Cause Mortality Rate at Day 42 |
11.9 | — |
| SECONDARY All Cause Mortality Rate at Day 84 |
16.3 | — |
Eligibility 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
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03583164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.