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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05421858




Registration number
NCT05421858
Ethics application status
Date submitted
7/06/2022
Date registered
16/06/2022

Titles & IDs
Public title
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Scientific title
An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis
Secondary ID [1] 0 0
2022-500455-23-00
Secondary ID [2] 0 0
FMGX-CS-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Candidemia 0 0
Candidiasis, Invasive 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Fosmanogepix
Treatment: Drugs - Fosmanogepix
Treatment: Drugs - Caspofungin
Treatment: Drugs - Fluconazole
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Fosmanogepix IV/oral - Fosmanogepix will be administered as an Intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to the oral form of fosmanogepix which is taken by mouth.

Matching placebos for caspofungin and fluconazole will also be administered (a placebo does not have any medicine in it but looks just like the caspofungin and fluconazole).

Active comparator: Caspofungin IV/ Fluconazole oral - Caspofungin will be administered as an intravenous (IV) infusion given directly into a vein. There is an option to switch from the IV infusion to oral fluconazole which is taken by mouth.

Matching placebos for fosmanogepix will also be administered (a placebo does not have any medicine in it but looks just like the medicine fosmanogepix being studied).


Treatment: Drugs: Fosmanogepix
IV infusion

Treatment: Drugs: Fosmanogepix
Oral tablet

Treatment: Drugs: Caspofungin
IV infusion

Treatment: Drugs: Fluconazole
Fluconazole oral capsule

Treatment: Drugs: Placebo
Matching placebo for caspofungin (IV infusion)

Treatment: Drugs: Placebo
Matching placebo for fluconazole (oral capsule)

Treatment: Drugs: Placebo
Matching placebo for fosmanogepix (IV infusion)

Treatment: Drugs: Placebo
Matching placebo for fosmanogepix (oral tablet)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients alive at Day 30
Timepoint [1] 0 0
Day 30
Primary outcome [2] 0 0
Proportion of patients with an overall response of treatment success at end of study treatment (EOST)
Timepoint [2] 0 0
EOST (up to Day 42)
Secondary outcome [1] 0 0
Proportion of patients with an overall response of treatment success at Day 14
Timepoint [1] 0 0
Day 14
Secondary outcome [2] 0 0
Proportion of patients with an overall response of treatment success at end of IV treatment (EOIV)
Timepoint [2] 0 0
up to Day 42
Secondary outcome [3] 0 0
Proportion of patients with an overall response of treatment success (sustained) at follow-up 6 weeks after EOST
Timepoint [3] 0 0
approximately up to 12,5 weeks
Secondary outcome [4] 0 0
Proportion of patients with clinical response of success at Day 14, EOIV, EOST, Follow-up 6- weeks after EOST
Timepoint [4] 0 0
Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST]
Secondary outcome [5] 0 0
Proportion of patients with mycological response of eradication or presumed eradication at Day 14, EOIV, EOST, Follow-up 6-weeks after EOST
Timepoint [5] 0 0
Day 14, EOIV (up to Day 42), EOST (up to Day 42), Follow-up 6-weeks after EOST
Secondary outcome [6] 0 0
Time to first negative blood culture in patients on fosmanogepix compared to caspofungin/fluconazole
Timepoint [6] 0 0
Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Secondary outcome [7] 0 0
Incidence of treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest (AESI)and AEs leading to discontinuation
Timepoint [7] 0 0
Screening up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Secondary outcome [8] 0 0
Number of patients with clinically significant laboratory abnormalities
Timepoint [8] 0 0
Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Secondary outcome [9] 0 0
Number of patients with abnormal neurological examination findings
Timepoint [9] 0 0
Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Secondary outcome [10] 0 0
Assessment of 12-lead electrocardiogram (ECGs)
Timepoint [10] 0 0
Baseline up to follow-up 6-weeks after EOST (approximately up to 12,5 weeks)
Secondary outcome [11] 0 0
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety)
Timepoint [11] 0 0
Day 3: 0, 3, 6, 9 and 24 hours post-dose; Day 7, 14, 21, 28, 35; EOST: 72 and 192 hours post-dose

Eligibility
Key inclusion criteria
1. Patients = 18 years (or the minimum country-specific age of consent if > 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study.
2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within = 96 hours (4 days) before randomization.
3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Existing infection

1. Infection known to be due to Candida krusei, in blood or any other normally sterile site.
2. Inappropriate fungal infection source control.
3. Diagnosis of certain deep-seated Candida infections.
2. Life expectancy of < 72 hours in the opinion of the investigator.
3. Requirement, or expected requirement, for hemodialysis.
4. Ongoing medical history of neurological disorders.
5. Patients with known human immunodeficiency virus infection, who have CD4+ count < 200/mm3 or viral load > 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
8. Received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia (e.g., > 2 doses of a once daily antifungal agent or > 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
10. Prior participation in this or any previous study of fosmanogepix.
11. Moderate or severe hepatic impairment, active viral hepatitis B or C, ALT or AST = 5 × ULN or total bilirubin > 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
12. Female patient is pregnant or lactating.
13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2028
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Monash Medical Center Clayton - Clayton
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Brugge
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Hasselt
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Yvoir
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Plovdiv
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
France
State/province [15] 0 0
Amiens
Country [16] 0 0
France
State/province [16] 0 0
Argenteuil
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Tours
Country [19] 0 0
Germany
State/province [19] 0 0
North Rhine-Westphalia
Country [20] 0 0
Greece
State/province [20] 0 0
Athens
Country [21] 0 0
Greece
State/province [21] 0 0
Piraeus
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Holon
Country [24] 0 0
Israel
State/province [24] 0 0
Ramat Gan
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
Country [26] 0 0
Israel
State/province [26] 0 0
Zerifin
Country [27] 0 0
Italy
State/province [27] 0 0
Cuneo
Country [28] 0 0
Italy
State/province [28] 0 0
Genoa
Country [29] 0 0
Italy
State/province [29] 0 0
Milan
Country [30] 0 0
Italy
State/province [30] 0 0
Pavia
Country [31] 0 0
Italy
State/province [31] 0 0
Pisa
Country [32] 0 0
Italy
State/province [32] 0 0
Trieste
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Daegu
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Suwon
Country [36] 0 0
South Africa
State/province [36] 0 0
Pretoria
Country [37] 0 0
Spain
State/province [37] 0 0
Catalonia
Country [38] 0 0
Taiwan
State/province [38] 0 0
Kaohsiung
Country [39] 0 0
Taiwan
State/province [39] 0 0
New Taipei City
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taipei
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taoyuan City
Country [42] 0 0
Thailand
State/province [42] 0 0
Hat Yai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Basilea Pharmaceutica
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Biomedical Advanced Research and Development Authority
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Manuel Häckl, MD
Address 0 0
Basilea Pharmaceutica International Ltd, Allschwil
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Manuel Häckl, MD
Address 0 0
Country 0 0
Phone 0 0
+41 76 302 53 10
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05421858