ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-Label Study to Evaluate Efficacy and Safety of SCY-078 in Patients With Refractory or Intolerant Fungal Diseases (FURI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03059992
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Invasive Candidiases Mucocutaneous Candidiasis Drug: SCY-078 Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open 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 in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SCY-078 Drug: SCY-078
Experimental Study Drug



Primary Outcome Measures :
  1. Assessment of Global Response [ Time Frame: Up to 90 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 [ Time Frame: 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 [ Time Frame: Day 42, Day 84 ]
    Proportion of surviving subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059992


Contacts
Contact: David Angulo, MD 201-884-5471 david.angulo@scynexis.com
Contact: Kristin Bennett 201-884-5469 kristin.bennett@scynexis.com

  Show 24 Study Locations
Sponsors and Collaborators
Scynexis, Inc.
Investigators
Study Director: David Angulo, MD Sponsor GmbH

Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT03059992     History of Changes
Other Study ID Numbers: SCY-078-301
2017-000381-29 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Candidiasis, Chronic Mucocutaneous
Invasive Fungal Infections
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases