Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Sponsor
Scynexis, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02244606
Collaborator
(none)
27
30
3
23
0.9
0

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: SCY-078 500 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.

Drug: SCY-078

Experimental: SCY-078 750 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.

Drug: SCY-078

Active Comparator: Standard-of-care

Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.

Drug: Fluconazole

Drug: Micafungin

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements [from time of informed consent through 6-weeks after last study drug]

  2. Dose of SCY-078 that achieves the target exposure (AUC) [during randomized study drug (administered for a maximum of 23 days)]

Secondary Outcome Measures

  1. Global response [end of all antifungal therapy (administered for a maximum of 28 days)]

  2. Clinical response [end of all antifungal therapy (administered for a maximum of 28 days)]

  3. Microbiological response [end of all antifungal therapy (administered for a maximum of 28 days)]

  4. Relapse [2-weeks and 6-weeks after the end of all antifungal therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.

  • Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

Exclusion Criteria:
  • Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.

  • Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.

  • Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.

  • Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233
2 UC Davis Medical Center Sacramento California United States 95817
3 University of Colorado Denver Aurora Colorado United States 80045
4 University of Miami Miami Florida United States 33125
5 Georgia Regents University Augusta Georgia United States 30912
6 University of Chicago Chicago Illinois United States 60637
7 Johns Hopkins University School of Medicine Baltimore Maryland United States 21205
8 Washington University School of Medicine Saint Louis Missouri United States 63110
9 Mercury Street Medical Group Butte Montana United States 59701
10 Albany Medical Center Albany New York United States 12208
11 Montefiore Medical Center Bronx New York United States 10467
12 University of North Carolina Chapel Hill North Carolina United States 27599
13 Duke University Medical Center Durham North Carolina United States 27710
14 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
15 Rhode Island Hospital Providence Rhode Island United States 02903
16 The Miriam Hospital Providence Rhode Island United States 02906
17 Medical University of South Carolina Charleston South Carolina United States 29425
18 Dallas VA Medical Center Dallas Texas United States 75216
19 Parkland Hospital Dallas Texas United States 75235
20 University of Texas Southwestern Medical Center Dallas Texas United States 75390
21 University of Texas Health Science Center at Houston Houston Texas United States 77030
22 South Texas Veterans Healthcare System San Antonio Texas United States 78229
23 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
24 University of Utah Hospitals and Clinics Salt Lake City Utah United States 84112
25 Hospital Militar Central San Salvador El Salvador
26 Hospital Rosales San Salvador El Salvador
27 University of Cologne Cologne North Rhine Westphalia Germany
28 Finca El Palomar Guatemala Guatemala Zona 16
29 Hospital Mario Catarino Rivas San Pedro Sula Cortes Honduras
30 Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula San Pedro Sula Cortes Honduras

Sponsors and Collaborators

  • Scynexis, Inc.

Investigators

  • Study Director: David Angulo, MD, Scynexis, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scynexis, Inc.
ClinicalTrials.gov Identifier:
NCT02244606
Other Study ID Numbers:
  • SCY-078-202
First Posted:
Sep 19, 2014
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020

Study Results

No Results Posted as of Oct 27, 2020