Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

Invasive Fungal Infections Clinical Trial

— FORMULA-OLS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583164
• Other study ID #: F901318/0032
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2018
• Est. completion date: April 2023

Study information

• Verified date: November 2022
• Source: F2G Biotech GmbH
• Contact: Daniea Zinzi
• Phone: 43 664 3582281
• Email: dzinzi[@]f2g.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2023
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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
• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• F901318
30mg tablets with a maximum daily dose of 300mg with dose adjustments according to plasma levels of F901318 and concomitant treatment with CYP inducers or inhibitors

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
F2G Biotech GmbH	Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Vietnam,  Australia,  Belgium,  Brazil,  Egypt,  France,  Germany,  Israel,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DRC adjudicated overall response at Day 42 using a combination of clinical, mycological and radiological response	DRC adjudicated overall response at Day 42 using a combination of clinical, mycological using a combination of clinical, mycological and radiological results	Day 42
Secondary	DRC adjudicated response at other time points, investigator assessed overall response, all cause mortality.	Assessment of overall response will be based on all available assessments (clinical, radiological and mycological). See response assessments listed below.; Treatment "success" is defined as complete or partial.; Treatment "failure" is defined as stable response or progression of IFD. The criteria for assessment of overall response are summarised below: Success -complete, Success -partial, Failure -stable, Failure -progression.	Days 7, 14, 28, End Of Treatment (anytime during the study between first administration and Day 84), 84 and 4-week FU
Secondary	Clinical response	The Investigator will identify and assess clinical signs and symptoms related to the IFD reported for each patient. Response assessment will be based on changes from baseline signs and symptoms	Day 7, Day 14, Day 28, Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU
Secondary	Where appropriate for the IFD, radiological response	As relevant for the IFD under study, baseline radiological assessments of IFD will be performed at screening and during the course of the study in accordance with local practice and as clinically indicated.; A = 90% improvement.; A = 50 to < 90% improvement.; A = 25% to < 50% improvement.; No Change to < 25% improvement.; Worsening in aggregate (across all lesions if more than one lesion).; No signs on radiological images at screening.; Results not available (i.e. assessment not performed at scheduled time-point).	Day 7, Day 14, Day 28, Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU
Secondary	Mycological response by pathogen	Assessment of mycological response as follows: Eradication of original causative organism cultured or identified by histology/cytology at baseline and no emergence of new causative organisms.; Presumed eradication - missing documentation of eradication of causative organism and no evidence of new causative organisms + resolution of all or some clinical symptoms and physical findings of IFD.; Persistence of the original causative organism cultured or identified by histology/cytology at baseline or emergence of a new causative organism.; Presumed persistence - missing documentation of persistence of causative organism and no documentation of emergence of new causative organisms + either (i) no resolution or (ii) worsening of any clinical symptoms and physical findings of IFD.; No mycological Follow-up results available (no diagnostic test done at the scheduled time-point).; No mycological evidence at baseline (negative diagnostic test(s) or not done).	Day 7, Day 14, Day 28, Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU
Secondary	Investigator-assessed overall response	(integration of clinical, radiological, and mycological response) see above.	Day 7, Day 14, Day 28, Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU
Secondary	All-cause mortality	All-cause mortality will be assessed using survival status and, if applicable, death details will be recorded in the CRF	Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU