Study to test effectiveness and safety of a new drug, Ibrexafungerp in patients with fungal diseases who do not easily respond to, are resistent to or who are intolerant to, the current treatment for their disease.
- Conditions
- Patients > 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant, resistant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-000381-29-DE
- Lead Sponsor
- SCYNEXIS, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
1. 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 or resistant to SOC, has relapsed after, or the subject has intolerance to or demonstrated toxicities resulting from an approved SOC antifungal treatment (as defined in study protocol 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 (isolate is resistant to or has a high MIC and is unlikely to respond to antifungal SOC) or logistical circumstances or if other antifungal alternatives are not appropriate.
3. 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 studyrelated 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.
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.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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.
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.
12. Subject or legal representative is/are unable to provide written informed consent for any reason.
13. Subject is unlikely to comply with protocol requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method