FORMULA-OLS: Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

• Sponsor: F2G Biotech GmbH (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03583164
• Collaborator: Iqvia Pty Ltd (Industry)
• Enrollment: 200
• Locations: 84
• Arm: 1
• Anticipated Duration (Months): 57.8
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Drug: F901318	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 6, 2018
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F901318 open-label single-arm of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options.	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

Outcome Measures

Primary Outcome Measures

1. DRC adjudicated overall response at Day 42 using a combination of clinical, mycological and radiological response [Day 42]

   DRC adjudicated overall response at Day 42 using a combination of clinical, mycological using a combination of clinical, mycological and radiological results

Secondary Outcome Measures

1. DRC adjudicated response at other time points, investigator assessed overall response, all cause mortality. [Days 7, 14, 28, End Of Treatment (anytime during the study between first administration and Day 84), 84 and 4-week FU]

   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.

2. Clinical response [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]

   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

3. Where appropriate for the IFD, radiological response [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]

   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).

4. Mycological response by pathogen [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]

   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).

5. Investigator-assessed overall response [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]

   (integration of clinical, radiological, and mycological response) see above.

6. All-cause mortality [Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU]

   All-cause mortality will be assessed using survival status and, if applicable, death details will be recorded in the CRF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Fever Institute at Kern Medical Center	Bakersfield	California	United States	93306
2	UC Davis Medical Center	Sacramento	California	United States	95817
3	University of California San Diego Medical Center	San Diego	California	United States	92103
4	Emory University	Atlanta	Georgia	United States	30322
5	University of Chicago	Chicago	Illinois	United States	60637
6	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
7	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
8	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
9	Weill Cornell Medical College	New York	New York	United States	10065
10	Stony Brook University Medical Center	Stony Brook	New York	United States	11794-0001
11	Duke University Health System	Durham	North Carolina	United States	27710
12	UPMC	Pittsburgh	Pennsylvania	United States	15213
13	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
14	The University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
15	St Vincent's Hospital Sydney	Darlinghurst	New South Wales	Australia	2010
16	Westmead Hospital	Westmead	New South Wales	Australia	2145
17	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
18	Peter MacCallum Centre-East Melbourne	Melbourne	Victoria	Australia	3000
19	Royal Melbourne Hospital	Melbourne	Victoria	Australia	3000
20	The Alfred Hospital	Melbourne	Victoria	Australia	3004
21	Fiona Stanley Hospital	Murdoch	Western Australia	Australia	6150
22	UZ Leuven	Leuven	Waals-Brabant	Belgium	3000
23	Institut Jules Bordet	Brussels		Belgium	1000
24	Hôpital Erasme	Bruxelles		Belgium	1070
25	Hospital Felício Rocho	Belo Horizonte	Minas Gerais	Brazil	30110-934
26	Santa Casa de Misericórdia de Belo Horizonte	Belo Horizonte	Minas Gerais	Brazil	30150-221
27	HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná	Curitiba	Paraná	Brazil	80060-900
28	Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90020-090
29	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
30	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
31	Hospital da Universidade Federal de Santa Maria CEP/UFSM	Santa Maria	Rio Grande Do Sul	Brazil	97105-900
32	Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer	Curitiba		Brazil	81520-060
33	Santa Casa de Misericórdia de Passos	Passos		Brazil	37904-020
34	Alexandria University Hospital	Alexandria		Egypt	21131
35	Cairo University Hospitals	Cairo		Egypt	11559
36	Ain Shams University Hospital	Cairo		Egypt	11566
37	Air Force Specialized Hospital	Cairo		Egypt	11566
38	National Cancer Institute	Cairo		Egypt	11796
39	Nasser Institute	Cairo		Egypt	12655
40	Oncology Center, Mansoura University	Mansoura		Egypt	35516
41	CHU Strasbourg - Hôpital Hautepierre	Strasbourg cedex	Bas Rhin	France	67091
42	CHU de Grenoble - Hôpital Albert Michallon	Grenoble	Isere	France	38043
43	Hôpital Necker - Enfants Malades	Paris cedex 15	Paris	France	75015
44	Hôpital Saint-Louis	Paris cedex 10		France	75475
45	Klinikum der Universitaet Muenchen Campus Grosshadern	Muenchen	Bayern	Germany	81377
46	Universitaetsklinikum Koeln	Koeln	Nordrhein Westfalen	Germany	50937
47	Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berlin		Germany	12200
48	Charite-Campus Benjamin Franklin (CBF)	Berlin		Germany	12200
49	Soroka University Medical Center	Beer-Sheva		Israel	84001
50	Rambam Health Care Campus	Haifa		Israel	3109601
51	Hadassah University Hospital - Ein Kerem	Jerusalem		Israel	9112001
52	Chaim Sheba Medical Center	Ramat Gan		Israel	52363
53	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	6423906
54	Asan Medical Center	Seoul		Korea, Republic of	05505
55	Samsung Medical Center	Seoul		Korea, Republic of	06351
56	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
57	Radboudumc	Nijmegen		Netherlands	6525 GA
58	Erasmus Medisch Centrum	Rotterdam		Netherlands	3015 CE
59	UMC Utrecht	Utrecht		Netherlands	3584 CX
60	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-214
61	SPZOZ Szpital Uniwersytecki w Krakowie	Krakow		Poland	31-501
62	Wojewodzki Szpital Specjalistyczny im. J. Korczaka	Slupsk		Poland	76-200
63	Instytut Hematologii i Transfuzjologii	Warszawa		Poland	02-776
64	BHI of Omsk region "Clinical Oncology Dispensary"	Omsk		Russian Federation	644013
65	Leningrad Regional Clinical Hospital	Saint Petersburg		Russian Federation	194291
66	FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"	Saint Petersburg		Russian Federation
67	Pavlov First Saint Petersburg State Medical University	Saint Petersburg		Russian Federation
68	SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH	Saint Petersburg		Russian Federation
69	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
70	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
71	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
72	Hospital Universitari i Politecnic La Fe	Valencia		Spain	46021
73	Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700
74	King Chulalongkorn Memorial Hospital	Pathum Wan	Bangkok	Thailand	10330
75	Dicle University, Medical Faculty	Diyarbakır		Turkey	21280
76	Acibadem Atakent Hospital	Istanbul		Turkey	34303
77	Marmara University Pendik Research and Training Hospital	Istanbul		Turkey	34899
78	King's College Hospital	London	Greater London	United Kingdom	SE5 9NU
79	Manchester Royal Infirmary	Manchester	Greater Manchester	United Kingdom	M13 9WL
80	Wythenshawe Hospital	Manchester	Wythenshawe	United Kingdom	M23 9LT
81	Bach Mai Hospital	Hanoi		Vietnam	100000
82	National Lung Hospital	Hanoi		Vietnam	10000
83	HCMC Hospital for Tropical Diseases	Ho Chi Minh		Vietnam	00000
84	Blood Transfusion Hematology Hospital	Ho Chi Minh		Vietnam	0000

Sponsors and Collaborators

• F2G Biotech GmbH
• Iqvia Pty Ltd

Investigators

• Principal Investigator: Sharon Chen, Westmead Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: F2G Biotech GmbH
• ClinicalTrials.gov Identifier: NCT03583164
• Other Study ID Numbers: F901318/0032
• First Posted: Jul 11, 2018
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by F2G Biotech GmbH: Anti fungal; Invasive aspergillosis; Rare moulds
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Olorofim

Study Results

No Results Posted as of Jul 20, 2022