Clinical trial NCT03583164: Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Invasive Fungal Infections
Keywords: Anti fungal
Invasive aspergillosis
Rare moulds
Coccidioidomycosis
Lead sponsor: F2G Biotech GmbH
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2018-07-11
Enrollment: 203
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

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.

Primary outcomes:
measure: Data Review Committee (DRC) Adjudicated Overall Response at Day 42
timeFrame: Day 42 in the Main Phase of study treatment
Secondary outcomes:
measure: DRC Adjudicated Overall Response at Day 42 for All Aspergillus
timeFrame: Day 42 in the Main Phase of study treatment
measure: DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans
timeFrame: 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
measure: DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species
timeFrame: Day 42 in the Main Phase of study treatment
measure: DRC Adjudicated Overall Response at Day 42 for Coccidioides Species
timeFrame: Day 42 in the Main Phase of study treatment
measure: DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi
timeFrame: Day 42 in the Main Phase of study treatment
measure: DRC Adjudicated Overall Response at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
measure: Investigator Assessed Overall Response at Day 42
timeFrame: Day 42 in the Main Phase of study treatment
measure: Investigator Assessed Overall Response at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
measure: DRC Adjudicated Clinical Response at Day 42
timeFrame: Day 42 in the Main phase of study treatment
measure: DRC Adjudicated Clinical Response at Day 84
timeFrame: Day 84 in the Main phase of study treatment
measure: Investigator Assessed Clinical Response at Day 42
timeFrame: Day 42 in the Main phase of study treatment
measure: Investigator Assessed Clinical Response at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
measure: DRC Adjudicated Mycological Response at Day 42
timeFrame: Day 42 in the Main Phase of study treatment
measure: DRC Adjudicated Mycological Response at Day 84
timeFrame: Day 84 in the Main phase of study treatment
measure: Investigator Assessed Mycological Response at Day 42
timeFrame: Day 42 in the Main Phase of study treatment
measure: Investigator Assessed Mycological Response at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
measure: DRC Adjudicated Radiological Response at Day 42
timeFrame: Day 42 in the Main phase of study treatment
measure: DRC Adjudicated Radiological Response at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
measure: Investigator Assessed Radiological Response at Day 42
timeFrame: Day 42 in the Main Phase of study treatment
measure: Investigator Assessed Radiological Response at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
measure: All Cause Mortality Rate at Day 42
timeFrame: Day 42 in the Main Phase of study treatment
measure: All Cause Mortality Rate at Day 84
timeFrame: Day 84 in the Main Phase of study treatment
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Valley Fever Institute at Kern Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Centre-East Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Leuven
country: Belgium
facility: UZ Leuven
state: Waals-Brabant
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Belo Horizonte
country: Brazil
facility: Hospital Felício Rocho
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
state: Minas Gerais
city: Curitiba
country: Brazil
facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná
state: Paraná
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Santa Maria
country: Brazil
facility: Hospital da Universidade Federal de Santa Maria CEP/UFSM
state: Rio Grande Do Sul
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
city: Passos
country: Brazil
facility: Santa Casa de Misericórdia de Passos
city: Alexandria
country: Egypt
facility: Alexandria University Hospital
city: Cairo
country: Egypt
facility: Cairo University Hospitals
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Cairo
country: Egypt
facility: Air Force Specialized Hospital
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Cairo
country: Egypt
facility: Nasser Institute
city: Mansoura
country: Egypt
facility: Oncology Center, Mansoura University
city: Strasbourg cedex
country: France
facility: CHU Strasbourg - Hôpital Hautepierre
state: Bas Rhin
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
state: Isere
city: Paris cedex 15
country: France
facility: Hôpital Necker - Enfants Malades
state: Paris
city: Paris cedex 10
country: France
facility: Hôpital Saint-Louis
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen Campus Grosshadern
state: Bayern
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein Westfalen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite-Campus Benjamin Franklin (CBF)
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Saint Petersburg
country: Russian Federation
facility: SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Pathum Wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
city: Diyarbakır
country: Turkey
facility: Dicle University, Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Atakent Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: Wythenshawe
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: National Lung Hospital
city: Ho Chi Minh
country: Vietnam
facility: HCMC Hospital for Tropical Diseases
city: Ho Chi Minh
country: Vietnam
facility: Blood Transfusion Hematology Hospital
Study officials:
affiliation: Westmead Hospital
name: Sharon Chen
role: PRINCIPAL_INVESTIGATOR
References: