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Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

Trial Status: Active

Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.

Inclusion Criteria

  • Subject is a male or female adult ≥18 years of age on the day the study informed consent form (ICF) is signed.
  • Subject has a probable or proven IPA based on EORTC-MSG criteria.
  • Subject has a result of a serum GMI ≥0.5 from a sample obtained within the 96 hours preceding enrollment into the study (Baseline/Treatment Day 1).
  • Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation OR
  • Subject who either recently resolved or ongoing neutropenia (neutropenia defined as absolute neutrophil count < 0.5 x 109/L [< 500/mm3] for > 10 days), temporally related to the onset of fungal disease OR
  • Subject who received treatment with other recognized T-cell immunosuppressants (such as cyclosporine, tacrolimus, monoclonal antibodies or nucleoside analogs) during the past 90 days including solid organ transplant patients OR
  • Subject with inherited severe immunodeficiency (e.g. chronic granulomatous disease, severe combined immunodeficiency)
  • Subject has not received more than 4 days (96 hours) of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study (Baseline/Treatment Day 1). However, subjects who have received more than 4 days but less than 7 days of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study may be enrolled but will require approval from the study medical monitor, who will evaluate each subject on a case-by-case basis.
  • Subject has an IPA episode that, in the investigator´s judgement, requires antifungal therapy and may be adequately treated with voriconazole (i.e., the IPA is not a breakthrough infection while receiving a mold-active azole antifungal [voriconazole, posaconazole, isavuconazole or itraconazole] that requires therapy with a non-azole antifungal agent).

Exclusion Criteria

  • Subject has a fungal disease with central nervous system involvement suspected at Screening.
  • Subject is receiving, has received or anticipates to be receiving concomitant medications that are listed in the prohibited medication list (Appendix A in full protocol) within the specified washout periods.
  • Subject has a Karnofsky score <20.
  • Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed.
  • Subject is under mechanical ventilation.
  • Subject has abnormal liver test parameters: AST or ALT >5 x ULN and/or total bilirubin >2.5 x ULN.

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

This is a multicenter, randomized, double-blind, two-arm study to evaluate the safety, tolerability, efficacy and PK of the coadministration of SCY-078 plus voriconazole compared to those of voriconazole in male and female subjects 18 years of age and older with a hematological malignancy (HM) or a myelodysplastic syndrome or aplastic anemia or hematopoietic cell transplantation (HCT) and a probable or proven invasive pulmonary aspergillosis based on EORTCMSG criteria. In addition, all subjects must be positive (≥0.5) for serum GMI.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Scynexis, Inc.

  • Primary ID SCY-078-206
  • Secondary IDs NCI-2019-04112, 2018-002565-18
  • Clinicaltrials.gov ID NCT03672292