candidiasis fungal disease
Conditions
Interventions
Patients eligible receive a first dose of 750 mg SCY-078 (3 tablets of 250 mg)
twice daily (BID) for the first 2 days of treatment and then further oral doses
of 750 mg once daily (QD) during max 90
Sponsors
SCYNEXIS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is a male or female adult *18 years of age on the day the study informed consent form (ICF) is signed. 2. Subject has a documented eligible fungal disease that has been refractory to, has relapsed after, or the subject has intolerance to or demonstrated toxicities resulting from an approved SOC antifungal treatment (as defined in Table 5). The subject is also eligible if, in the judgement of the Investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances or if other antifungal alternatives are not appropriate. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube. 4. Subject and/or legal guardian is/are able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures. 5. Subject and/or legal guardian is 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 US, a Health Insurance Portability and Accountability Act [HIPAA] authorization form). 6. Subject and/or legal guardian is able to understand and follow all study-related procedures including study drug administration. 7. Subject is not pregnant and is highly unlikely to become pregnant or to impregnate a partner since he/she meets at least one of the following criteria: a. Subject is a female subject who is not of reproductive potential and is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as one who: (1) has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (3) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (i.e., anorexia nervosa). b. Subject is a male subject who is not of reproductive potential and is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as one who has undergone a successful vasectomy. A successful vasectomy is defined as (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy. c. Subject is a male or female subject who is of reproductive potential and agrees to remain abstinent if it is the subject*s preferred method of contraception, or, if sexually active, use (or have their partner use) 2 acceptable methods of contraception starting from the time of consent through 28 days after the completion of study therapy. Acceptable methods of birth control are hormonal contraception (including but not limited to oral, injectable or implantable methods), intrauterine device, diaphragm with spermicide, condom, and vasectomy. Hormonal contraception (including but not limited to oral, injectable or implantable methods), must not be used alone as a method of contraception because it is unknown if the eff
Exclusion criteria
Exclusion criteria: 1. Subject has an invasive fungal disease with central nervous system involvement unless the subject is planned to receive combination therapy with ibrexafungerp and other antifungal. 2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters, devices, identified undrained abscess) that is likely to be the source of the fungal disease. 3. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support. 4. Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with a diagnosis of Gilbert*s disease are not excluded. 5. Subject is unlikely to survive 30 days. 6. Subject has 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. 7. Subject requires treatment with the prohibited medications. 8. Subject has known hypersensitivity to ibrexafungerp. 9. Subject is pregnant or lactating. 10. Subject has received any other investigational drug (i.e., new chemical entity) within at least 30 days (or 5 and a half half-lives of the investigational product) before signing the ICF. 11. Subject is an employee of SCYNEXIS, Inc., the Investigator, or contract research organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling*s offspring) of an employee involved in the study. Subject or legal representative is/are unable to provide written informed consent for any reason. 13. Subject is unlikely to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints * Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the DMC * Safety as measured by: physical examination, vital signs, adverse events, 12-lead electrocardiogram (ECG) and laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Efficacy as measured by: * Percentage of subjects with a recurrence of the baseline fungal infection within 42 days after EoT * Percentage of subjects surviving 42 and 84 days after Day 1 (first dose of study drug) | — |
Countries
Netherlands
Outcome results
None listed