NL-OMON55351已完成3 期
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) - FURI
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- SCYNEXIS
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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
- •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.
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