Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion
George Thomposn

Description

Summary

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of 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.

Official Title

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

Details

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of SCY-078 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 SCY-078 for up to 90 days.

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 11 treatment visits, a follow-up visit and 2 follow-up contacts.

Keywords

Invasive Candidiases Mucocutaneous Candidiasis Candidiasis Candidiasis, Invasive Mycoses Candidiasis, Chronic Mucocutaneous SCY-078

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Be ≥ 18 years of age with 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. Must 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.

You CAN'T join if...

  1. An invasive fungal disease with CNS, cardiac or eye involvement.
  2. A life expectancy < 3 days.
  3. Subjects has a known or estimated creatinine clearance of <20 mL/min by Cockroft Gault. Estimated creatinine clearance = [(140-age) x weight in Kg]/[72x serum creatinine in mg/dL) [x 0.85 if female]. Subjects undergoing dialysis.
  4. 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. Patients with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded.
  5. There is inappropriate fungal infection source control e.g., persistent catheters, devices, identified abscess likely to be the source of the fungal infection.
  6. Subject is hemodynamically unstable or and/or requiring vasopressor medication for blood pressure support.
  7. Subject requires treatment with the prohibited medications.
  8. Subject with a known hypersensitivity to SCY-078 drug under study.
  9. Subject with < 500 absolute neutrophils per mL at baseline. NOTE: Patients with an absolute neutrophil count (ANC) < 500/mm3 who are receiving G-CSF are allowed to enroll if the patient is expected to recover from the severe neutropenia (ANC < 500/mm3) in 3 to 5 days after starting with G-CSF treatment and if the patient is expected to meet inclusion/exclusion criteria at the time of reevaluation.
  10. . Subject is pregnant or lactating.
  11. . Subject has used an investigational drug within 30 days prior to the baseline visit.
  12. . Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
  13. . Prolonged QTc (Fridericia's correction: QTc = QT/RR0.33) > 480 findings on the baseline ECG or other abnormalities deemed clinically significant by the investigator that would put the subject at unacceptable risk for participation in the study.

Locations

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • University of Texas Southwestern Medical Center Dallas accepting new patients
    Dallas Texas 75390-8589 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Scynexis, Inc.
Links
Sign up for this study
ID
NCT03059992
Phase
Phase 3
Study Type
Interventional
Last Updated