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)
- Conditions
- candidiasisfungal disease10017528
- Registration Number
- NL-OMON55351
- Lead Sponsor
- SCYNEXIS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints<br /><br>* Efficacy as measured by the percentage of subjects with global success<br /><br>(complete or partial global response) at EoT as determined by the DMC<br /><br>* Safety as measured by: physical examination, vital signs, adverse events,<br /><br>12-lead electrocardiogram (ECG) and laboratory tests</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints<br /><br>Efficacy as measured by:<br /><br>* Percentage of subjects with a recurrence of the baseline fungal infection<br /><br>within 42 days<br /><br>after EoT<br /><br>* Percentage of subjects surviving 42 and 84 days after Day 1 (first dose of<br /><br>study drug)</p><br>