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The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCY-078 500 mg | Experimental | A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. |
|
| SCY-078 750 mg | Experimental | A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. |
|
| Standard-of-care | Active Comparator | Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCY-078 | Drug |
| ||
| Fluconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements | All Related TEAEs by SOC and PT, by Treatment, Safety | up to 10 weeks |
| Dose of SCY-078 That Achieves the Target Exposure (AUC) | Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK | 0 to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Global Response | Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture) | end of all antifungal therapy (administered for a maximum of 28 days) |
| Clinical Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Angulo, MD | Scynexis, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| UC Davis Medical Center |
A total of 27 participants were enrolled, two of whom failed to meet all inclusion and exclusion criteria and were considered screen failures. Among the 25 enrolled participants who met all inclusion and exclusion criteria, three were not randomized. Thus, 22 patients were randomized to receive SCY-078 500 mg or SCY-078 750 mg or standard-of-care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibrexafungerp 500-mg | A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. |
| FG001 | Ibrexafungerp 750-mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Micafungin | Drug |
|
Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy
| end of all antifungal therapy (administered for a maximum of 28 days) |
| Microbiological Response | Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection | end of all antifungal therapy (administered for a maximum of 28 days) |
| Relapse | If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered | 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks |
| Sacramento |
| California |
| 95817 |
| United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| University of Miami | Miami | Florida | 33125 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercury Street Medical Group | Butte | Montana | 59701 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Parkland Hospital | Dallas | Texas | 75235 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| South Texas Veterans Healthcare System | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84112 | United States |
| Hospital Militar Central | San Salvador | El Salvador |
| Hospital Rosales | San Salvador | El Salvador |
| University of Cologne | Cologne | North Rhine-Westphalia | Germany |
| Finca El Palomar | Guatemala City | Zona 16 | Guatemala |
| Hospital Mario Catarino Rivas | San Pedro Sula | Cortés Department | Honduras |
| Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula | San Pedro Sula | Cortés Department | Honduras |
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
| FG002 | Standard of Care (Fluconazole) | Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day |
| FG003 | Standard of Care (Micafungin) | IV micafungin 100 mg daily |
| Did Not Receive Study Drug |
|
| Did Not Complete Randomized Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibrexafungerp 500-mg | A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. |
| BG001 | Ibrexafungerp 750-mg | A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. |
| BG002 | Standard of Care (Fluconazole) | Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day |
| BG003 | Standard of Care (Micafungin) | IV micafungin 100 mg daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements | All Related TEAEs by SOC and PT, by Treatment, Safety | ITT | Posted | Count of Participants | Participants | up to 10 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Dose of SCY-078 That Achieves the Target Exposure (AUC) | Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK | Pharmacokinetic Population | Posted | Count of Participants | Participants | 0 to 24 hours post-dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Global Response | Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture) | ITT | Posted | Count of Participants | Participants | end of all antifungal therapy (administered for a maximum of 28 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response | Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy | ITT | Posted | Count of Participants | Participants | end of all antifungal therapy (administered for a maximum of 28 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Response | Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection | Posted | Count of Participants | Participants | end of all antifungal therapy (administered for a maximum of 28 days) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Relapse | If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered | Intent-To-Treat (ITT): All randomized participants Overall number of participants includes all randomized participants, number analyzed includes participants analyzed at a particular time point. | Posted | Count of Participants | Participants | No | 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrexafungerp 500-mg | A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. | 0 | 6 | 2 | 6 | 5 | 6 |
| EG001 | Ibrexafungerp 750-mg | A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. | 1 | 7 | 4 | 7 | 4 | 7 |
| EG002 | Standard of Care (Fluconazole) | Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day | 1 | 7 | 3 | 7 | 4 | 7 |
| EG003 | Standard of Care (Micafungin) | IV micafungin 100 mg daily | 0 | 1 | 0 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess neck | Infections and infestations | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Fungemia | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute lymphocytic leukemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Small cell lung cancer extensive stage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Femur Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Renal tubular necrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Angulo | SCYNEXIS | (201) 884 - 5471 | david.angulo@scynexis.com |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D058365 | Candidiasis, Invasive |
| D058387 | Candidemia |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D002177 | Candidiasis |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
| D015725 | Fluconazole |
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Patients with no Drug- Related TEAE |
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| Units | Counts |
|---|---|
| Participants |
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|---|---|
| Participants |
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| Units |
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| Counts |
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| Participants |
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IV micafungin 100 mg daily
|
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| Did Not Relapse |
|
| Not Evaluable or Missing |
|