EUCTR2021-000541-41-HU进行中（未招募）1 期
European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - EU-SolidAct
Oslo University Hospital0 个研究点目标入组 2,000 人开始时间: 2021年5月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subject aged 18 to 75 years (inclusive) at the time of signing the informed consent.
- •2. Subject has histologically confirmed cancer.
- •3. Subject is treated with an oral or injectable commercially-available EGFRi or MEKi therapy (alone or in
- •combination). Note: EGFRi or MEKi therapy must be started within 12 weeks prior to Day 1.
- •4. Subject has EGFRi/MEKi-related acneiform rash of Grade = 2 as per CTCAE Version 5.0, and = 20
- •inflammatory lesions on the face at screening and Day 1.
- •5. Subject has an ECOG performance score between 0 and 2.
- •6. Subject has a life expectancy of = 6 months at Day 1.
- •7. Subject meets the following laboratory criteria at screening:
- •a) Hemoglobin = 90 g/L (= 9 g/dL);
- •b) White blood cell count = 3.0 × 109/L (= 3.0 × 103/µL);
- •c) Platelets = 100 × 109/L (= 100 × 103/µL);
- •d) Serum creatinine =1.5 × upper limit of normal (ULN) and creatinine clearance = 50 mL/min;
- •e) ALT and AST = 2.5 × ULN with no liver metastases and = 5 x ULN in presence of liver
- •metastases;
- •f) Total bilirubin = 1.5 × ULN. Subjects with known Gilbert’s disease who have serum
- •bilirubin < 3 × ULN may be included;
- •g) Absolute Neutrophils Count > 1.5 × 103/µL.
- •Note: Due to the enrollment of immunocompromised subjects in the study whose laboratory
- •normal ranges may be greatly variable compared to other conditions, the final determination of
- •eligibility based on laboratory parameters may be done after Investigator assessment following
- •consultation with the Medical Monitor and Sponsor.
- •8. Subject has a body mass index (BMI) within the range of 18 to 38 kg/m2, inclusive {BMI = weight
- •(kg)/[height (m)]2}.
- •9. Subject has no clinically significant medical condition (other than cancer) or
- •physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put
- •the subject at undue risk or interfere with interpretation of study results.
- •10.Contraceptive use by men and women should be consistent with local regulations regarding the
- •methods of contraception for those participating in clinical studies.
- •Contraception and pregnancy:
- •a) A male subject must agree to use contraception as detailed in Appendix 1 of this protocol
- •during the treatment period and for at least 220 days (which includes the duration of
- •relevant exposure plus the duration of sperm cycle) after the last study treatment
- •administration and refrain from donating sperm during this period.
- •b) Female subjects:
- •i. A woman of childbearing potential (WOCBP) is eligible to participate if she has a
- •negative serum pregnancy test (beta-human chorionic gonadotropin) at screening
- •and a negative urine pregnancy test at Day 1 (see Appendix 1), is not breastfeeding,
- •and agrees to follow the contraceptive guidance in Appendix 1 during the
- •treatment period and for at least 6 months after receiving the study treatment and
- •refrains from donating oocytes for assisted reproduction during this period. The
- •female subject’s selected form of contraception must be effective by the time the
- •female subject enters into the study at Day 1 (eg, hormonal contraception should
- •be initiated at least 48 days before Day 1). For WOCBP, hormonal contraceptives must be used on a stable regimen during the study treatment. Starting hormonal contraceptives during the study is not permitted.
- •Note: Drospirenone, chlormadinone acetate, or cyproterone acetate must be initiated and used on a stable regimen at least 26 weeks prior to Day 1.
- •ii. A woman not of childbearing potential, as defined in
排除标准
- •1.Subject has infected EGFRi/MEKi-associated acneiform rash
- •2. Subject has other malignancies or medical conditions which may interfere with the ability to evaluate the subject’s response to therapy
- •3. Subject has significant skin disease other than EGFRi/MEKi-induced acneiform rash
- •4. Subject has a history of clinically significant cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral or psychiatric disease, or other major uncontrolled disease
- •5. Subject has a history of chronic or recurrent infectious disease within 6 months prior to screening
- •6. Subject has a history of a serious infection that led to hospitalization or treatment with IV antibiotics or antiviral treatment for an infection within 3 months prior to screening or any recent infection requiring systemic antibiotic within 1 week of Day 1, or systemic antiviral treatment within 4 weeks of Day 1
- •7. Subject has a history or any evidence of active that required systemic antibiotics within 1 week of Day 1 or other systemic treatment within 4 weeks of Day 1
- •8. Subject has any factors that would predispose the subject to develop an infection
- •9. Subject has a history of an opportunistic infection within 6 months prior to screening
- •10.Subject has a history of a herpes zoster infection within 2 months prior to screening
- •11.Subject has a known or suspected autoimmune disorder for which a subject requires medical follow-up or medical treatment
- •12.Subject has any history of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status not related to their cancer diagnosis or treatment
- •13.Subject had any major surgery within 2 weeks of Day 1
- •14.Subject has a history of any significant drug allergy or reaction and reactivity to polysorbate 20, a component of ANB019 formulation, or the inactive ingredients
- •15.Subject has taken the following drugs within the specified period prior to Day 1:
- •a) an over-the-counter (OTC) topical medication for the treatment of acne, including topical anti-inflammatory medications, corticosteroids, or antibacterial/antiseptic soap or wash within 1 week prior to Day 1
- •b) prescription topical retinoid or other prescription topical medications for the treatment of acne within 4 weeks prior to Day 1, or antimicrobials within 1 week prior to Day 1
- •c) systemic antibiotics within 1 week prior to Day 1
- •d) topical agents or systemic agents that could affect pruritus within 2 weeks prior to Day 1
- •e) other systemic antiacne drugs not mentioned in other exclusion criteria within 4 weeks prior to Day 1
- •f) oral or injectable corticosteroids within 4 weeks prior to Day 1 or require them during the study
- •g) a facial procedure within 8 weeks prior to Day 1
- •h) photodynamic therapy or phototherapy with blue or red light within 12 weeks prior to Day 1
- •i) androgen receptor blockers within 12 weeks prior to Day 1
- •j) live attenuated vaccine within 12 weeks prior to Day 1
- •k) drospirenone, chlormadinone acetate, or cyproterone acetate on an unstable dose and frequency within 26 weeks prior to Day 1
- •l) oral retinoid or vitamin A supplements >10,000 U/d within 12 weeks prior to Day 1
- •m) nonbiological investigational drug to treat cancer within 2 weeks prior to Day 1, or any other nonbiological investigational drug within 4 weeks or 5 half-lives prior to Day 1
- •n) marketed or investigational biological agent to treat cancer within 2 weeks prior to Day 1, or any other marke
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