A Phase 2 interventional study of Olorofim in Invasive Fungal Infections, sponsored by F2G Biotech GmbH. Completed at 82 sites in 17 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by F2G Biotech GmbH · Phase 2, Interventional, and Treatment
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 203 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →F2G Biotech GmbH is the lead sponsor of 20 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Olorofim (F901318) was given orally for up to 90 days in the Main Study Phase and could be continued for those participants entering the Extended Treatment Phase. Patients received fixed doses comprising of a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day. Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg.
Drug: Olorofim
30mg oral tablets
Also known as: F901318
Data Review Committee (DRC) Adjudicated Overall Response at Day 42
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
Time frame: Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for All Aspergillus
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline. The Aspergillus- All category is a combination of participants with Aspergillus proven and Aspergillus probable (invasive aspergillosis lower respiratory tract disease) baseline disease category. Overall success is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent Data Review Committee using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Lomentospora prolificans. Success is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Scedosporium species. Success is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for Coccidioides Species
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to Coccidioides species. Success is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to other olorofim susceptible fungi. Success is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 84
DRC-adjudicated overall response at Day 84, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on the EORTC/MSG criteria. For the analysis of overall response rate, values were assigned to the DRC-adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Study Visit could not be collected or participants who were considered not evaluable at the Study Visit).
Time frame: Day 84 in the Main Phase of study treatment
Investigator Assessed Overall Response at Day 42
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 42, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 42 could not be collected or who were considered not evaluable at the specific visit).
Time frame: Day 42 in the Main Phase of study treatment
Investigator Assessed Overall Response at Day 84
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 84, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 84 could not be collected or who were considered not evaluable at the specific visit).
Time frame: Day 84 in the Main Phase of study treatment
DRC Adjudicated Clinical Response at Day 42
DRC adjudicated clinical response at the Day 42 Study Visit, as determined by an independent Data Review Committee using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main phase of study treatment
DRC Adjudicated Clinical Response at Day 84
DRC adjudicated clinical response at the Day 84 Study Visit, as determined by an independent DRC using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Time frame: Day 84 in the Main phase of study treatment
Investigator Assessed Clinical Response at Day 42
Investigator assessed clinical response at the Day 42 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Time frame: Day 42 in the Main phase of study treatment
Investigator Assessed Clinical Response at Day 84
Investigator assessed clinical response at the Day 84 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
Time frame: Day 84 in the Main Phase of study treatment
DRC Adjudicated Mycological Response at Day 42
DRC adjudicated mycological response was assessed at the Day 42 Study Visit, as determined by an independent Data Review Committee using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Time frame: Day 42 in the Main Phase of study treatment
DRC Adjudicated Mycological Response at Day 84
DRC adjudicated mycological response was assessed at the Day 84 Study Visit, as determined by an independent DRC using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Time frame: Day 84 in the Main phase of study treatment
Investigator Assessed Mycological Response at Day 42
Mycological response was assessed by the Investigator at the Day 42 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Time frame: Day 42 in the Main Phase of study treatment
Investigator Assessed Mycological Response at Day 84
Mycological response was assessed by the Investigator at the Day 84 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
Time frame: Day 84 in the Main Phase of study treatment
DRC Adjudicated Radiological Response at Day 42
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
Time frame: Day 42 in the Main phase of study treatment
DRC Adjudicated Radiological Response at Day 84
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
Time frame: Day 84 in the Main Phase of study treatment
Investigator Assessed Radiological Response at Day 42
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
Time frame: Day 42 in the Main Phase of study treatment
Investigator Assessed Radiological Response at Day 84
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
Time frame: Day 84 in the Main Phase of study treatment
All Cause Mortality Rate at Day 42
The all cause mortality rate at Day 42 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
Time frame: Day 42 in the Main Phase of study treatment
All Cause Mortality Rate at Day 84
The all cause mortality rate at Day 84 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
Time frame: Day 84 in the Main Phase of study treatment
This study planned to enrol approximately 200 patients at approximately 100 centres globally over at least 60 months. The first patient was enrolled into the study on 06 June 2018 and the Last subject last visit date was 10 February 2023 (for the Extended Treatment Phase).
| Milestone | Olorofim (F901318) |
|---|---|
| Started | 203 |
| Completed | 126 |
| Not completed | 77 |
| Withdrew: Death in main phase | 35 |
| Withdrew: Lost to follow up in main phase | 1 |
| Withdrew: Lost to follow up in extended phase | 3 |
| Withdrew: Clinically significant lab value in main phase | 2 |
| Withdrew: Clinically significant lab value in extended phase | 4 |
| Withdrew: Physician decision in main phase | 1 |
| Withdrew: Physician decision in extended phase | 2 |
| Withdrew: Death in extended phase | 13 |
| Withdrew: Intolerable adverse event in main phase | 3 |
| Withdrew: Intolerable adverse event in extended phase | 1 |
| Withdrew: Lack of compliance in extended phase | 2 |
| Withdrew: Treatment failure in main phase | 2 |
| Withdrew: Treatment failure in extended phase | 4 |
| Withdrew: Withdrawal of consent in extended phase | 2 |
| Withdrew: Other not specified reason in main phase | 2 |
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Data Review Committee (DRC) Adjudicated Overall Response at Day 42 | 28.7 (22.6 to 35.5) |
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline. The Aspergillus- All category is a combination of participants with Aspergillus proven and Aspergillus probable (invasive aspergillosis lower respiratory tract disease) baseline disease category. Overall success is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Overall Response at Day 42 for All Aspergillus | 34.7 (25.5 to 44.8) |
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent Data Review Committee using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Lomentospora prolificans. Success is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans | 42.3 (23.4 to 63.1) |
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with a proven infection due to Scedosporium species. Success is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species | 36.4 (17.2 to 59.3) |
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to Coccidioides species. Success is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Overall Response at Day 42 for Coccidioides Species | 0.0 (0.0 to 8.6) |
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on EORTC/MSG criteria. This was also presented by each of the 5 major infections as adjudicated by the DRC at baseline, this one is for participants with proven infection due to other olorofim susceptible fungi. Success is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi | 33.3 (9.9 to 65.1) |
DRC-adjudicated overall response at Day 84, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on the EORTC/MSG criteria. For the analysis of overall response rate, values were assigned to the DRC-adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Study Visit could not be collected or participants who were considered not evaluable at the Study Visit).
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Overall Response at Day 84 | 27.2 (21.2 to 33.9) |
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 42, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 42 could not be collected or who were considered not evaluable at the specific visit).
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Investigator Assessed Overall Response at Day 42 | 24.8 (19.0 to 31.3) |
Investigator-assessed overall response (as determined by the Investigator using all available assessment results including clinical, mycological and radiologic results based on the EORTC/MSG criteria) at Day 84, categorised by the same response criteria as in the primary endpoint: Success (Success-Complete, Success-Partial), Failure (Failure-Stable, Failure-Progression, Death, participants for whom data at Day 84 could not be collected or who were considered not evaluable at the specific visit).
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Investigator Assessed Overall Response at Day 84 | 29.7 (23.5 to 36.5) |
DRC adjudicated clinical response at the Day 42 Study Visit, as determined by an independent Data Review Committee using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Clinical Response at Day 42 | 59.9 (52.8 to 66.7) |
DRC adjudicated clinical response at the Day 84 Study Visit, as determined by an independent DRC using clinical response results based on EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Clinical Response at Day 84 | 54.0 (46.8 to 61.0) |
Investigator assessed clinical response at the Day 42 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Investigator Assessed Clinical Response at Day 42 | 53.5 (46.3 to 60.5) |
Investigator assessed clinical response at the Day 84 Study Visit using clinical response results based on the EORTC/MSG criteria. Resolution is defined as a Complete or Partial Response.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Investigator Assessed Clinical Response at Day 84 | 56.4 (49.3 to 63.4) |
DRC adjudicated mycological response was assessed at the Day 42 Study Visit, as determined by an independent Data Review Committee using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Mycological Response at Day 42 | 18.3 (13.1 to 24.4) |
DRC adjudicated mycological response was assessed at the Day 84 Study Visit, as determined by an independent DRC using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| DRC Adjudicated Mycological Response at Day 84 | 22.5 (16.9 to 28.9) |
Mycological response was assessed by the Investigator at the Day 42 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Investigator Assessed Mycological Response at Day 42 | 25.7 (19.9 to 32.3) |
Mycological response was assessed by the Investigator at the Day 84 Study Visit using mycological response results based on EORTC/MSG criteria. Success is defined as eradication or presumed eradication.
| Response rate percentage | Olorofim (F901318) |
|---|---|
| Investigator Assessed Mycological Response at Day 84 | 31.7 (25.3 to 38.6) |
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
| Participants | Olorofim (F901318) |
|---|---|
| At least 90 percent improvement | 11 |
| At least 50 to less than 90 percent improvement | 10 |
| At least 25 to less than 50 percent improvement | 12 |
| Stable findings (0 to less than 25 percent improvement) | 55 |
| Worsening response | 6 |
| No signs on Radiological images at Screening | 7 |
| Not evaluable | 75 |
| Not relevant | 2 |
| Missing | 0 |
| Death (from any cause) | 24 |
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84 and were adjudicated by an independent DRC. Radiological responses were assigned as per EORTC/MSG criteria.
| Participants | Olorofim (F901318) |
|---|---|
| At least 90 percent improvement | 14 |
| At least 50 to less than 90 percent improvement | 11 |
| At least 25 to less than 50 percent improvement | 5 |
| Stable findings (0 to less than 25 percent improvement) | 36 |
| Worsening response | 6 |
| No signs on Radiological images at Screening | 5 |
| Not evaluable | 71 |
| Not relevant | 2 |
| Missing | 21 |
| Death (from any cause) | 31 |
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 42. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
| Participants | Olorofim (F901318) |
|---|---|
| At least 90 percent improvement | 10 |
| At least 50 to less than 90 percent improvement | 20 |
| At least 25 to less than 50 percent improvement | 20 |
| Stable findings (0 to less than 25 percent improvement) | 29 |
| Worsening response | 11 |
| No signs on Radiological images at Screening | 3 |
| Not evaluable | 69 |
| Missing | 16 |
| Death (from any cause) | 24 |
In participants for whom radiology formed a part of their diagnosis, radiology evaluations were required on Day 84. Radiological responses were assessed by the Investigator using EORTC/MSG criteria.
| Participants | Olorofim (F901318) |
|---|---|
| At least 90 percent improvement | 23 |
| At least 50 to less than 90 percent improvement | 16 |
| At least 25 to less than 50 percent improvement | 16 |
| Stable findings (0 to less than 25 percent improvement) | 26 |
| Worsening response | 10 |
| No signs on Radiological images at Screening | 4 |
| Not evaluable | 52 |
| Missing | 24 |
| Death (from any cause) | 31 |
The all cause mortality rate at Day 42 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
| Mortality rate percentage | Olorofim (F901318) |
|---|---|
| All Cause Mortality Rate at Day 42 | 11.9 (7.8 to 17.2) |
The all cause mortality rate at Day 84 uses the survival status that was entered at the study visit (which employs a window around each nominal study day).
| Mortality rate percentage | Olorofim (F901318) |
|---|---|
| All Cause Mortality Rate at Day 84 | 16.3 (11.5 to 22.2) |
Collected over Adverse events (AEs) were reported from the time of Informed consent through study completion, up to and including 4-week post-treatment follow-up. For patients in the main treatment phase of the study only, the median duration of study treatment was 84 days. For those entering the extended treatment phase, the median duration of study treatment was 308 days (approximately 10 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olorofim (F901318) | 50/203 (24.6%) | 132/203 (65%) | 186/203 (91.6%) |
| Event | Olorofim (F901318) |
|---|---|
| PneumoniaInfections and infestations | 13/203 |
| PyrexiaGeneral disorders | 9/203 |
| COVID-19Infections and infestations | 8/203 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 8/203 |
| Hepatic enzyme increasedInvestigations | 7/203 |
| Liver function test increasedInvestigations | 7/203 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/203 |
| Meningitis coccidioidesInfections and infestations | 5/203 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 4/203 |
| Aspergillus infectionInfections and infestations | 4/203 |
| Event | Olorofim (F901318) |
|---|---|
| DiarrhoeaGastrointestinal disorders | 42/203 |
| NauseaGastrointestinal disorders | 40/203 |
| VomitingGastrointestinal disorders | 40/203 |
| HeadacheNervous system disorders | 32/203 |
| PyrexiaGeneral disorders | 29/203 |
| Liver function test increasedInvestigations | 22/203 |
| CoughRespiratory, thoracic and mediastinal disorders | 19/203 |
| Oedema peripheralGeneral disorders | 19/203 |
| COVID-19Infections and infestations | 18/203 |
| FatigueGeneral disorders | 18/203 |
| Age, Categorical(Participants) | Olorofim (F901318) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 151 |
| >=65 years | 52 |
| Age, Continuous(years) | Olorofim (F901318) |
|---|---|
| Median | 56.57 (18.0 to 90.4) |
| Sex: Female, Male(Participants) | Olorofim (F901318) |
|---|---|
| Female | 79 |
| Male | 124 |
| Race (NIH/OMB)(Participants) | Olorofim (F901318) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 16 |
| White | 160 |
| More than one race | 2 |
| Unknown or Not Reported | 11 |
| Region of Enrollment(participants) | Olorofim (F901318) |
|---|---|
| United States | 96 |
| Egypt | 1 |
| United Kingdom | 3 |
| Thailand | 2 |
| Spain | 6 |
| Russia | 3 |
| Netherlands | 16 |
| Belgium | 45 |
| Israel | 8 |
| Australia | 18 |
| Germany | 5 |
| Body Mass Index(kg/m^2) | Olorofim (F901318) |
|---|---|
| Median | 22.954 (14.21 to 43.23) |
| Baseline Data Review Committee-Adjudicated Disease Category(Participants) | Olorofim (F901318) |
|---|---|
| Aspergillus - All | 101 |
| Lomentospora (Scedosporium) prolificans | 26 |
| Scedosporium spp. | 22 |
| Other Olorofim-susceptible fungi | 12 |
| Coccidioides | 41 |
| No DRC adjudicated baseline fungus | 1 |
| Reason for Limited Treatment Options(Participants) | Olorofim (F901318) |
|---|---|
| Known/predicted resistance to all licensed agents | 42 |
| Failure of available therapy | 110 |
| Intolerance to available therapy | 29 |
| Inability to manage drug interactions | 7 |
| Inability to produce therapeutic drug levels | 2 |
| IV only option produced clinical response and standard to switch to oral azole | 10 |
| Other, received Medical Monitor approval | 2 |
| Missing | 1 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results can be available to researchers after the primary publication of results for this study, after deidentification (text, tables, figures, appendices)
Supporting information: Study protocol, Sap
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