Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options

Last updated: July 9, 2024
Sponsor: F2G Biotech GmbH
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Olorofim

Clinical Study ID

NCT03583164
F901318/0032
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female aged at least 18 years, or male and female aged 16 years or 17 yearsand 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 sexualintercourse or use a highly effective means of contraception

  • Participants with invasive fungal disease

  • Participants who have limited alternative treatment options

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.

  • Known history of allergy, hypersensitivity, or any serious reaction to any componentof the study drug.

  • Participants with chronic aspergillosis, aspergilloma or allergic bronchopulmonaryaspergillosis.

  • Human Immunodeficiency Virus (HIV) infection but not currently receivingantiretroviral therapy.

  • Participants with a medical condition that may jeopardize adherence to the protocolor may cause unacceptable additional risk to the participant

  • Previously enrolled participants or participants enrolled in any clinical trialwithin the last 30 days

  • Participants receiving treatment limited to supportive care due to predicted shortsurvival time.

  • Prohibited concomitant medications.

  • Any exclusion criteria required by local regulatory authorities.

Study Design

Total Participants: 203
Treatment Group(s): 1
Primary Treatment: Olorofim
Phase: 2
Study Start date:
June 06, 2018
Estimated Completion Date:
February 10, 2023

Study 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.

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Peter MacCallum Centre-East Melbourne

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • UZ Leuven

    Leuven, Waals-Brabant 3000
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Brussels, 1000
    Belgium

    Site Not Available

  • Hôpital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais 30110-934
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, Minas Gerais 30150-221
    Brazil

    Site Not Available

  • HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná

    Curitiba, Paraná 80060-900
    Brazil

    Site Not Available

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

  • Hospital da Universidade Federal de Santa Maria CEP/UFSM

    Santa Maria, Rio Grande Do Sul 97105-900
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, 81520-060
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia de Passos

    Passos, 37904-020
    Brazil

    Site Not Available

  • Alexandria University Hospital

    Alexandria, 21131
    Egypt

    Site Not Available

  • Ain Shams University Hospital

    Cairo, 11566
    Egypt

    Site Not Available

  • Air Force Specialized Hospital

    Cairo, 11566
    Egypt

    Site Not Available

  • Cairo University Hospitals

    Cairo, 11559
    Egypt

    Site Not Available

  • Nasser Institute

    Cairo, 12655
    Egypt

    Site Not Available

  • National Cancer Institute

    Cairo, 11796
    Egypt

    Site Not Available

  • Oncology Center, Mansoura University

    Mansoura, 35516
    Egypt

    Site Not Available

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg cedex, Bas Rhin 67091
    France

    Site Not Available

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, Isere 38043
    France

    Site Not Available

  • Hôpital Necker - Enfants Malades

    Paris cedex 15, Paris 75015
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris cedex 10, 75475
    France

    Site Not Available

  • Klinikum der Universitaet Muenchen Campus Grosshadern

    Muenchen, Bayern 81377
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Koeln, Nordrhein Westfalen 50937
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200
    Germany

    Site Not Available

  • Charite-Campus Benjamin Franklin (CBF)

    Berlin, 12200
    Germany

    Site Not Available

  • Soroka University Medical Center

    Beer-Sheva, 84001
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 52363
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Radboudumc

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Site Not Available

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

    Slupsk, 76-200
    Poland

    Site Not Available

  • Instytut Hematologii i Transfuzjologii

    Warszawa, 02-776
    Poland

    Site Not Available

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013
    Russian Federation

    Site Not Available

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46021
    Spain

    Site Not Available

  • Siriraj Hospital

    Bangkoknoi, Bangkok 10700
    Thailand

    Site Not Available

  • King Chulalongkorn Memorial Hospital

    Pathum Wan, Bangkok 10330
    Thailand

    Site Not Available

  • King Chulalongkorn Memorial Hospital

    Pathumwan, Bangkok 10330
    Thailand

    Site Not Available

  • Dicle University, Medical Faculty

    Diyarbakır, 21280
    Turkey

    Site Not Available

  • Acibadem Atakent Hospital

    Istanbul, 34303
    Turkey

    Site Not Available

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34899
    Turkey

    Site Not Available

  • King's College Hospital

    London, Greater London SE5 9NU
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, Greater Manchester M13 9WL
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, Wythenshawe M23 9LT
    United Kingdom

    Site Not Available

  • Valley Fever Institute at Kern Medical Center

    Bakersfield, California 93306
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California San Diego Medical Center

    San Diego, California 92103
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794-0001
    United States

    Site Not Available

  • Duke University Health System

    Durham, North Carolina 27710
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Bach Mai Hospital

    Hanoi, 100000
    Vietnam

    Site Not Available

  • National Lung Hospital

    Hanoi, 10000
    Vietnam

    Site Not Available

  • Blood Transfusion Hematology Hospital

    Ho Chi Minh, 0000
    Vietnam

    Site Not Available

  • HCMC Hospital for Tropical Diseases

    Ho Chi Minh, 00000
    Vietnam

    Site Not Available

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