Open-Label Study to Evaluate Efficacy and Safety of SCY-078 in Patients With Refractory or Intolerant Fungal Diseases
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | April 1, 2017 |
End Date: | December 2019 |
Contact: | David Angulo, MD |
Email: | david.angulo@scynexis.com |
Phone: | 201-884-5471 |
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)
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.
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.
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.
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.
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.
We found this trial at
20
sites
Pittsburgh, Pennsylvania 15260
Principal Investigator: Minh-Hong Nguyen, MD
Phone: 412-648-6536
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Peter Pappas, MD
Phone: 205-934-9661
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5323 Harry Hines Blvd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Ricardo LaHoz, MD
Phone: 214-648-9464
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Luis Ostrosky-Zeichner, MD
Phone: 713-704-4137
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Jo-Anne Young, MD
Phone: 612-626-3798
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Gowri Satyanarayana, MD
Phone: 615-343-0266
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Sacramento, California 95814
Principal Investigator: George Thomposn, MD
Phone: 916-734-8033
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550 Peachtree St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: George Lyon, MD
Phone: 404-712-7245
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Augusta, Georgia 30912
Principal Investigator: Jose Vazquez, MD
Phone: 706-721-0309
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1215 Lee St
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-996-7623
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Kathleen Mullane, MD
Phone: 773-702-1665
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2 Auenbruggerplatz
Graz, 8036
Graz, 8036
Principal Investigator: Robert Krause, PD Dr. med.
Phone: +43 316 385 30046
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: David Andes, MD
Phone: 608-262-8156
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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New Orleans, Louisiana 70112
Principal Investigator: Michael Hagensee, MD
Phone: 504-568-7740
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433 Bolivar Street
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Principal Investigator: Michael Hagensee, MD
Phone: 504-210-3403
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New York, New York 10021
Principal Investigator: Thomas Walsh, MD
Phone: 212-746-6320
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Andrej Spec, MD
Phone: 314-747-1096
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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101 Nicolls Rd
Stony Brook, New York 11794
Stony Brook, New York 11794
(631) 444-4000
Principal Investigator: Roderick Go, MD
Phone: 631-638-0844
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Winston-Salem, North Carolina 27157
Principal Investigator: John Sanders, MD
Phone: 336-716-3266
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