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

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)

Sponsors

Lead Sponsor: Scynexis, Inc.

Source Scynexis, Inc.
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.

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.

Overall Status Recruiting
Start Date 2017-04-01
Completion Date 2022-12-01
Primary Completion Date 2022-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Assessment of Global Response Up to 180 days of study treatment
Secondary Outcome
Measure Time Frame
Assessment of Recurrence of Baseline Fungal Infection up to 42 days after end of study treatment
Assessment of survival Day 42, Day 84
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ibrexafungerp

Description: Experimental Study Drug

Arm Group Label: Ibrexafungerp (SCY-078)

Other Name: SCY-078

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
David Angulo, MD Study Director Sponsor GmbH
Overall Contact

Last Name: Nkechi Azie, MD

Phone: 201-688-2243

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
University of Alabama at Birmingham | Birmingham, Alabama, 35294-0006, United States Recruiting William Atkinson 205-934-9651 [email protected] Peter Pappas, MD Principal Investigator
UC Davis Medical Center | Sacramento, California, 95817, United States Recruiting Trina Reynolds 916-734-6483 [email protected] George Thomposn, MD Principal Investigator
University of California San Francisco | San Francisco, California, 94143, United States Recruiting Shraddha Pandey 408-368-9388 [email protected] Peter Chin-Hong, MD Principal Investigator
Emory University Hospital Midtown | Atlanta, Georgia, 30322, United States Recruiting Delaney Morris 404-712-7194 [email protected] George Lyon, MD Principal Investigator
Augusta University | Augusta, Georgia, 30912, United States Recruiting Aprile Osborn 706-721-0309 [email protected] Jose Vazquez, MD Principal Investigator
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Recruiting Colin Goodbred 617-726-7697 [email protected] Sarah Hammond, MD Principal Investigator
University of Michigan | Ann Arbor, Michigan, 48109, United States Recruiting Andrea Woods 734-936-3981 [email protected] Marisa Miceli, MD Principal Investigator
Wayne State University | Detroit, Michigan, 48201, United States Recruiting Nicole Woznicki 313-451-0351 [email protected] Jack Sobel, MD Principal Investigator
University of Minnesota | Minneapolis, Minnesota, 55455, United States Recruiting Lindsey Raymond 612-626-3798 [email protected] Jo-Anne Young, MD Principal Investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Ella Nadarevic 319-429-6144 [email protected] Paschalis Vergidis, MD Principal Investigator
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting Sarah Hubert 314-747-1922 [email protected] Andrej Spec, MD Principal Investigator
Memorial Sloan Kettering Cancer Center | New York, New York, 10021, United States Recruiting Rebekah Goetz 646-608-2776 [email protected] Yeon Lee, MD Principal Investigator
Weill Cornell Medical College | New York, New York, 10065, United States Recruiting Rosypriya Kodiyanplakkal, MD Thomas Walsh, MD Principal Investigator
Stony Brook University Medical Center | Stony Brook, New York, 11794, United States Recruiting Zita Makselyte 631-638-0844 [email protected] Roderick Go, MD Principal Investigator
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting Diane Wright 919-668-5571 [email protected]
Wake Forest Baptist Medical Center | Winston-Salem, North Carolina, 27157, United States Recruiting Rica Abbot 336-713-1395 [email protected] John Sanders, MD Principal Investigator
University of Pittsburg Medical Center | Pittsburgh, Pennsylvania, 15203, United States Recruiting Kailey Hughes 412-648-6453 [email protected] Minh-Hong Nguyen, MD Principal Investigator
University of Texas Southwestern Medical Center Dallas | Dallas, Texas, 75390-8589, United States Recruiting Kirstie LeDoux 214-648-9464 [email protected] Ricardo LaHoz, MD Principal Investigator
University of Texas Health Science Center at Houston | Houston, Texas, 77030, United States Recruiting Mehriban Mammadova 713-500-6761 [email protected] Luis Ostrosky-Zeichner, MD Principal Investigator
University of Wisconsin | Madison, Wisconsin, 53705, United States Recruiting Meg Bayless 608-262-8156 David Andes, MD Principal Investigator
Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine | Graz, 8036, Austria Recruiting Jurgen Prattes +43 316 385 30046 [email protected] Robert Krause, PD Dr. med. Principal Investigator
Medical University Innsbruck | Innsbruck, 6020, Austria Recruiting Petra Decristoforo 0049 6676 8716 72722 [email protected] Günter Weiss, Prof. Dr. Principal Investigator Stephan Eschertzhuber, Prof. Dr. Sub-Investigator
Universitätsklinikum Köln, Klinik I für Innere Medizin | Cologne, 50937, Germany Recruiting Susanna Proske 0221 478-85504 [email protected] Oliver Cornely, Prof MD Principal Investigator
Universitätsklinikum Essen, Klinik für Infektiologie | Essen, 45147, Germany Recruiting Gerlinde Augustiniak 0049 201 723 6022 [email protected] Oliver Witzke, Prof MD Principal Investigator
Universitätsklinikum Frankfurt, Department of Internal Medicine II | Frankfurt, 60590, Germany Recruiting Franziska Ebeling 0049 69 6301 6140 [email protected] Christoph Stephan, Prof. Dr. Principal Investigator
Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology | Leipzig, 04129, Germany Recruiting Ulrike Schmidt 0049 341 909 4472 [email protected] Bernhard Ruf, Prof MD Principal Investigator
LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III | Munich, 81377, Germany Recruiting Marta Illenyi 0049 89 4400 75211 [email protected] Helmut Ostermann, Prof. Dr. Principal Investigator
Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8 | Nijmegen, Gelderland, 6525, Netherlands Recruiting Sonja Sloots-Cuppen, MD +31 627 034 783 [email protected] Prof. Frank van de Veerdonk Principal Investigator
Aga Khan University | Karachi, 74800, Pakistan Recruiting Shazia Abrar Faisal Mahmood, MD Principal Investigator
Johese Clinical Research | Lyttelton, Centurion, 0154, South Africa Recruiting Leh Watkins +27 12 942 0825 [email protected] Martie Conradie, Dr. Principal Investigator
Into Research | Groenkloof, Pretoria, 0181, South Africa Recruiting Maria Booysen +27 12 460 1160 [email protected] Richard S Siebert, Dr. Principal Investigator
Emmed Research | Muckleneuck, Pretoria, 0002, South Africa Recruiting Hendrihet van Rensburg +27 12 343 6844 [email protected] Johannes Breedt, Dr. Principal Investigator
FCRN Clinical Trial Centre | Three Rivers, Vereeniging, 1935, South Africa Recruiting Michelle Mans (016) 100-6051 [email protected] Johan Geldenhuys, Doctor Principal Investigator
Hospital General Universitario Gregorio Marañón | Madrid, 28007, Spain Recruiting Patricia Munoz, MD 0034 914 265 184 [email protected] Patricia Munoz, MD Principal Investigator
Hospital Universitari i Politecnic La Fe | Valencia, 46026, Spain Recruiting Maria Tasias, MD 0034 96 124 40 00 [email protected] Maria Tasias, MD Principal Investigator
St. George's University of London | London, SW17 0RE, United Kingdom Recruiting Elizabeth Cruddas 0044 20 8725 3320 [email protected] Tania Bicanic Principal Investigator
The University of Manchester | Manchester, M13 9PL, United Kingdom Recruiting Riina Richardson, MD 0044 75 459 949 59 [email protected] Riina Richardson, MD Principal Investigator
Location Countries

Austria

Germany

Netherlands

Pakistan

South Africa

Spain

United Kingdom

United States

Verification Date

2022-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ibrexafungerp (SCY-078)

Type: Experimental

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

Acronym FURI
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Open label, non-comparator, single arm

Primary Purpose: Treatment

Masking: None (Open Label)

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