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FURI: Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

Sponsor
Scynexis, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03059992
Collaborator
(none)
200
Enrollment
37
Locations
1
Arm
68
Anticipated Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.

Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.

Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.

Following a screening visit, there will be up to 15 treatment visits, a follow-up visit and 2 follow-up contacts.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label, non-comparator, single armOpen label, non-comparator, single arm
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)
Actual Study Start Date :
Apr 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ibrexafungerp (SCY-078)

Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.

Drug: Ibrexafungerp
Experimental Study Drug
Other Names:
  • SCY-078

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of Global Response [Up to 180 days of study treatment]

      The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.

    Secondary Outcome Measures

    1. Assessment of Recurrence of Baseline Fungal Infection [up to 42 days after end of study treatment]

      The proportion of subjects with a recurrence of the baseline fungal infectoin

    2. Assessment of survival [Day 42, Day 84]

      Proportion of surviving subjects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment

    2. Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube

    3. Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.

    4. Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).

    5. Be able to understand and follow all study-related procedures including study drug administration.

    6. Agree to use a medically acceptable method of contraception while receiving protocol-assigned product.

    Key Exclusion Criteria:

    1. An invasive fungal disease with CNS involvement.

    2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).

    3. Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.

    4. A life expectancy < 30 days.

    5. Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >10 x the upper limit of normal (ULN), and/or total bilirubin > 5 x ULN.

    6. Subject is pregnant or lactating.

    7. Subject has used an investigational drug within 30 days prior to the baseline visit.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294-0006
    2 UC Davis Medical Center Sacramento California United States 95817
    3 University of California San Francisco San Francisco California United States 94143
    4 Emory University Hospital Midtown Atlanta Georgia United States 30322
    5 Augusta University Augusta Georgia United States 30912
    6 Massachusetts General Hospital Boston Massachusetts United States 02114
    7 University of Michigan Ann Arbor Michigan United States 48109
    8 Wayne State University Detroit Michigan United States 48201
    9 University of Minnesota Minneapolis Minnesota United States 55455
    10 Mayo Clinic Rochester Minnesota United States 55905
    11 Washington University School of Medicine Saint Louis Missouri United States 63110
    12 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    13 Weill Cornell Medical College New York New York United States 10065
    14 Stony Brook University Medical Center Stony Brook New York United States 11794
    15 Duke University Medical Center Durham North Carolina United States 27710
    16 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157
    17 University of Pittsburg Medical Center Pittsburgh Pennsylvania United States 15203
    18 University of Texas Southwestern Medical Center Dallas Dallas Texas United States 75390-8589
    19 University of Texas Health Science Center at Houston Houston Texas United States 77030
    20 University of Wisconsin Madison Wisconsin United States 53705
    21 Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine Graz Austria 8036
    22 Medical University Innsbruck Innsbruck Austria 6020
    23 Universitätsklinikum Köln, Klinik I für Innere Medizin Cologne Germany 50937
    24 Universitätsklinikum Essen, Klinik für Infektiologie Essen Germany 45147
    25 Universitätsklinikum Frankfurt, Department of Internal Medicine II Frankfurt Germany 60590
    26 Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology Leipzig Germany 04129
    27 LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III Munich Germany 81377
    28 Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8 Nijmegen Gelderland Netherlands 6525
    29 Aga Khan University Karachi Pakistan 74800
    30 Johese Clinical Research Lyttelton Centurion South Africa 0154
    31 Into Research Groenkloof Pretoria South Africa 0181
    32 Emmed Research Muckleneuck Pretoria South Africa 0002
    33 FCRN Clinical Trial Centre Three Rivers Vereeniging South Africa 1935
    34 Hospital General Universitario Gregorio Marañón Madrid Spain 28007
    35 Hospital Universitari i Politecnic La Fe Valencia Spain 46026
    36 St. George's University of London London United Kingdom SW17 0RE
    37 The University of Manchester Manchester United Kingdom M13 9PL

    Sponsors and Collaborators

    • Scynexis, Inc.

    Investigators

    • Study Director: David Angulo, MD, Sponsor GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Scynexis, Inc.
    ClinicalTrials.gov Identifier:
    NCT03059992
    Other Study ID Numbers:
    • SCY-078-301
    • 2017-000381-29
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Candidiasis
    Aspergillosis
    Candidiasis, Vulvovaginal
    Candidiasis, Invasive
    Pulmonary Aspergillosis
    Invasive Pulmonary Aspergillosis
    Histoplasmosis
    Aspergillosis, Allergic Bronchopulmonary
    Mycoses
    Coccidioidomycosis
    Coccidiosis
    Blastomycosis
    Candidiasis, Chronic Mucocutaneous
    Ibrexafungerp

    Study Results

    No Results Posted as of Jul 26, 2022