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

Primary Purpose

Invasive Fungal Infections

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
F901318
Sponsored by
F2G Biotech GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Fungal Infections focused on measuring Anti fungal, Invasive aspergillosis, Rare moulds

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Valley Fever Institute at Kern Medical CenterRecruiting
  • UC Davis Medical CenterRecruiting
  • University of California San Diego Medical CenterRecruiting
  • Emory UniversityRecruiting
  • University of ChicagoRecruiting
  • Johns Hopkins HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Duke University Health SystemRecruiting
  • UPMCRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • The University of Texas Health Science Center at San AntonioRecruiting
  • St Vincent's Hospital Sydney
  • Westmead HospitalRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Peter MacCallum Centre-East MelbourneRecruiting
  • Royal Melbourne HospitalRecruiting
  • The Alfred HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • UZ LeuvenRecruiting
  • Institut Jules BordetRecruiting
  • Hôpital ErasmeRecruiting
  • Hospital Felício Rocho
  • Santa Casa de Misericórdia de Belo Horizonte
  • HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná
  • Santa Casa de Misericórdia de Porto Alegre
  • Hospital de Clínicas de Porto Alegre
  • Hospital São Lucas da PUCRS
  • Hospital da Universidade Federal de Santa Maria CEP/UFSM
  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
  • Santa Casa de Misericórdia de Passos
  • Alexandria University Hospital
  • Cairo University Hospitals
  • Ain Shams University Hospital
  • Air Force Specialized Hospital
  • National Cancer Institute
  • Nasser Institute
  • Oncology Center, Mansoura University
  • CHU Strasbourg - Hôpital Hautepierre
  • CHU de Grenoble - Hôpital Albert Michallon
  • Hôpital Necker - Enfants Malades
  • Hôpital Saint-Louis
  • Klinikum der Universitaet Muenchen Campus Grosshadern
  • Universitaetsklinikum KoelnRecruiting
  • Charite Universitaetsmedizin Berlin - Campus Benjamin FranklinRecruiting
  • Charite-Campus Benjamin Franklin (CBF)Recruiting
  • Soroka University Medical CenterRecruiting
  • Rambam Health Care CampusRecruiting
  • Hadassah University Hospital - Ein KeremRecruiting
  • Chaim Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • RadboudumcRecruiting
  • Erasmus Medisch CentrumRecruiting
  • UMC UtrechtRecruiting
  • Uniwersyteckie Centrum Kliniczne
  • SPZOZ Szpital Uniwersytecki w Krakowie
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
  • Instytut Hematologii i Transfuzjologii
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • Leningrad Regional Clinical HospitalRecruiting
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"Recruiting
  • Pavlov First Saint Petersburg State Medical UniversityRecruiting
  • SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RHRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Siriraj HospitalRecruiting
  • King Chulalongkorn Memorial HospitalRecruiting
  • Dicle University, Medical Faculty
  • Acibadem Atakent Hospital
  • Marmara University Pendik Research and Training Hospital
  • King's College Hospital
  • Manchester Royal Infirmary
  • Wythenshawe HospitalRecruiting
  • Bach Mai Hospital
  • National Lung Hospital
  • HCMC Hospital for Tropical Diseases
  • Blood Transfusion Hematology Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F901318

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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).
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).
Investigator-assessed overall response
(integration of clinical, radiological, and mycological response) see above.
All-cause mortality
All-cause mortality will be assessed using survival status and, if applicable, death details will be recorded in the CRF

Full Information

First Posted
May 17, 2018
Last Updated
November 30, 2022
Sponsor
F2G Biotech GmbH
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03583164
Brief Title
Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
F2G Biotech GmbH
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infections
Keywords
Anti fungal, Invasive aspergillosis, Rare moulds

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F901318
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
F901318
Intervention Description
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
Primary Outcome Measure Information:
Title
DRC adjudicated overall response at Day 42 using a combination of clinical, mycological and radiological response
Description
DRC adjudicated overall response at Day 42 using a combination of clinical, mycological using a combination of clinical, mycological and radiological results
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
DRC adjudicated response at other time points, investigator assessed overall response, all cause mortality.
Description
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.
Time Frame
Days 7, 14, 28, End Of Treatment (anytime during the study between first administration and Day 84), 84 and 4-week FU
Title
Clinical response
Description
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
Time Frame
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
Title
Where appropriate for the IFD, radiological response
Description
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).
Time Frame
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
Title
Mycological response by pathogen
Description
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).
Time Frame
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
Title
Investigator-assessed overall response
Description
(integration of clinical, radiological, and mycological response) see above.
Time Frame
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
Title
All-cause mortality
Description
All-cause mortality will be assessed using survival status and, if applicable, death details will be recorded in the CRF
Time Frame
Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniea Zinzi
Phone
43 664 3582281
Email
dzinzi@f2g.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Chen
Organizational Affiliation
Westmead Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Fever Institute at Kern Medical Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Royce Johnson
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George R. Thompson, III
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hoenigl
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Lyon
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Mullane
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shmuel Shoham
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Marty
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Spec
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Walsh
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Schuster
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Alexander
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minh Nguyen
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Granwehr
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Patterson
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Sharon
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Paterson
Facility Name
Peter MacCallum Centre-East Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Slavin
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Slavin
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orla Morrissey
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Heath
Facility Name
UZ Leuven
City
Leuven
State/Province
Waals-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Maertens
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aspasia Georgala
Facility Name
Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Hites
Facility Name
Hospital Felício Rocho
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-934
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelino Freire Junior
Facility Name
Santa Casa de Misericórdia de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antônio Tarcísio de Faria Freire
Facility Name
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80060-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávio de Queiroz Telles Filho
Facility Name
Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Marcel Berdun Stadnik
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zubaran Goldani Luciano
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabiano Ramos
Facility Name
Hospital da Universidade Federal de Santa Maria CEP/UFSM
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97105-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Vargas Schwarzbold
Facility Name
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Manuel Paz Morales
Facility Name
Santa Casa de Misericórdia de Passos
City
Passos
ZIP/Postal Code
37904-020
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscila Freitas Neves Goncalves
Facility Name
Alexandria University Hospital
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Zaki
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehad Tawfik
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Moussa
Facility Name
Air Force Specialized Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raafat Abdel Fatah
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thoraya Hamid
Facility Name
Nasser Institute
City
Cairo
ZIP/Postal Code
12655
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel Mooti
Facility Name
Oncology Center, Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Shamaa
Facility Name
CHU Strasbourg - Hôpital Hautepierre
City
Strasbourg cedex
State/Province
Bas Rhin
ZIP/Postal Code
67091
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul Herbrecht
Facility Name
CHU de Grenoble - Hôpital Albert Michallon
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Thiebaut
Facility Name
Hôpital Necker - Enfants Malades
City
Paris cedex 15
State/Province
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanny Lanternier
Facility Name
Hôpital Saint-Louis
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Bergeron-Lafaurie
Facility Name
Klinikum der Universitaet Muenchen Campus Grosshadern
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helmut Ostermann
Facility Name
Universitaetsklinikum Koeln
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Koehler
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Schwartz
Facility Name
Charite-Campus Benjamin Franklin (CBF)
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Schwartz
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lior Nesher
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Oren
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Korem
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52363
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galia Rahav
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronen Ben-Ami
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Han Kim
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyong Ran Peck
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Gun Lee
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Verweij
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Jan An Rijnders
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Bruns
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Bieniaszewska
Facility Name
SPZOZ Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Krawczyk
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Homenda
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marzena Watek
Facility Name
BHI of Omsk region "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Leningrad Regional Clinical Hospital
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Uspenskaya
Facility Name
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iiya Zyuzgin
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Afanasyev
Facility Name
SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolai Klimko
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Ruiz Camps
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Fortun Abete
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Maria Aguado Garcia
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46021
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amparo Sole Jover
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Methee Chayakulkeeree
Facility Name
King Chulalongkorn Memorial Hospital
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jutivorakool Kamonwan
Facility Name
Dicle University, Medical Faculty
City
Diyarbakır
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Celen
Facility Name
Acibadem Atakent Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iftihar Koksal
Facility Name
Marmara University Pendik Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zekaver Odabasi
Facility Name
King's College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9NU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Varun Mehra
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riina Richardson
Facility Name
Wythenshawe Hospital
City
Manchester
State/Province
Wythenshawe
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riina Richardson
Facility Name
Bach Mai Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Ngo
Facility Name
National Lung Hospital
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ngoc Nguyen
Facility Name
HCMC Hospital for Tropical Diseases
City
Ho Chi Minh
ZIP/Postal Code
00000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nguyen Phu Huong Lan
Facility Name
Blood Transfusion Hematology Hospital
City
Ho Chi Minh
ZIP/Postal Code
0000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ngoc Ngan Linh Ngo

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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