EUCTR2016-004611-13-BE进行中（未招募）1 期
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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. Age = 18 years
- •2. Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
- •3. Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy (immunotherapy treatment alone, ie, not administered with chemotherapy, should not be counted as a line of chemotherapy)
- •4. At least 1 target lesion that is measurable by RECIST, Version 1.1
- •5. Absolute neutrophil count = 1.5 × 109/L
- •6. Platelet count = 100 × 109/L
- •7. Creatinine = 1.5 mg/dL and creatinine clearance (CrCl) of = 60 mL/minute)
- •8. Total bilirubin = 1.5 × upper limit of normal (ULN)
- •9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; = 5 × ULN in the
- •presence of liver metastases
- •10. Serum albumin = 3 g/dL
- •11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •12. All clinically significant toxicities from previous anticancer therapy must have resolved to = Grade 1 (except for hemoglobin)
- •13. Contraception:
- •a. For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) test result at screening and negative serum or urine ß-hCG test result at baseline.
- •Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception in combination with a barrier method.
- •Acceptable surgical sterilization techniques are hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing, and bilateral oophorectomy, with surgery at least 2 months prior to dosing. Acceptable methods of contraception to be used in combination with a barrier method are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), or a vasectomized partner. These methods are to be utilized during the study and for 3 months after discontinuation of treatment
- •b. For males: Patients with female partner of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected, or implanted hormonal methods of contraception or an intrauterine device/system by the female partner, in combination with a barrier method (eg, condom, diaphragm, cervical cap) during the study and for 3 months after discontinuation of treatment, and will also refrain from sperm donation for 3 months following completion of the study
- •14. Able to understand and sign an informed consent
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. History of topotecan treatment for SCLC
- •2. Presence of brain metastases requiring immediate treatment with radiation therapy or steroids
- •3. History of other malignancies, except for the following:
- •(1) adequately treated basal or squamous cell carcinoma of the skin;
- •(2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or
- •(3) other curatively treated solid tumor with no evidence of disease for = 3 years
- •4. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
- •5. Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
- •6. Serious active infection
- •7. Psychiatric illness/social situations that would limit study compliance
- •8. Other uncontrolled serious chronic disease or conditions that in the investigator’s opinion could affect compliance or follow-up in the protocol
- •9. History of upper gastrointestinal bleeding, ulceration, perforation, or significant gastrointestinal disease within 12 months prior to study enrollment
- •10. Known human immunodeficiency virus (HIV) positive; known hepatitis B virus (HBV) positive; or known hepatitis C virus (HCV) positive that is symptomatic or requiring active therapy
- •11. Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for
- •determination of a response)
- •12. Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment
- •13. Receipt of any low-dose systemic chemotherapeutic agent given for a nononcologic purpose within 4 weeks prior to enrollment (eg, low-dose methotrexate for rheumatoid arthritis)
- •14. Hypersensitivity to any of the components of the formulation of topotecan
- •15. Legal incapacity or limited legal capacity
- •16. Pregnant or lactating women
研究者
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