EUCTR2017-000758-20-PL进行中（未招募）1 期
A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer
nited Therapeutics Corporation0 个研究点目标入组 470 人开始时间: 2018年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 470
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
- •3.1.1. Provide a signed informed consent form before any screening procedures.
- •3.1.2. Aged =18 years on the date of signing the informed consent form.
- •3.1.3. Have histologically or cytologically confirmed SCLC (undifferentiated small cell carcinoma arising in or consistent with lung cancer origin).
- •3.1.4. Documented (radiographic evidence of) relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
- •3.1.5. No more than 1 prior regimen for SCLC. First-line platinum-based
- •therapy followed by maintenance therapy is considered a single regimen
- •provided there is no intervening disease progression.
- •3.1.6. Have no curative therapy available.
- •3.1.7. Have a life expectancy of at least 12 weeks.
- •3.1.8. Have Eastern Cooperative Oncology Group (ECOG) performance
- •status of 0 or 1.
- •3.1.9. Have adequate bone marrow function as assessed by the following
- •laboratory test results:
- •- Hemoglobin =9.0 g/dL or =5.6 mmol/L (erythropoietin or transfusion
- •permitted).
- •- Absolute neutrophil count (ANC) =1,500/mm3 or =1.5 x 109/L
- •(growth factors permitted).
- •- Platelet count =100,000/mm3 or =100 x 109/L (transfusions or
- •thrombopoietic growth factors permitted).
- •3.1.10. Have calculated creatinine clearance (CrCL) =30 mL/minute
- •(using Cockcroft and Gault's formula) or serum creatinine =1.5 times
- •below the ULN.
- •3.1.11. Have adequate hepatic function, as assessed by the following
- •laboratory test results:
- •- Total bilirubin =1.5 times the ULN. (Subjects with Gilbert's Syndrome
- •or other benign congenital hyperbilirubinemia may be eligible at the
- •investigator's discretion in consultation with the Medical Monitor.
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
- •=3.0 times ULN in subjects without liver metastases or =5.0 times ULN in
- •subjects with liver metastases.
- •3.1.12. Women of reproductive potential must have a negative urine or
- •serum beta human chorionic gonadotropin (ß-HCG) pregnancy test
- •obtained within 7 days prior to the first dose of study treatment
- •(dinutuximab and/or chemotherapy)
- •- Women not of reproductive potential are female subjects who are
- •postmenopausal or permanently sterilized (e.g. tubal occlusion,
- •hysterectomy, bilateral salpingectomy).
- •3.1.13. Women of reproductive potential must agree to consistently use
- •one form of highly effective contraception plus one additional form of
- •contraception simultaneously or to practice complete abstinence from
- •vaginal intercourse. The requirement for two forms of contraception or
- •complete abstinence from vaginal intercourse applies from the time of
- •informed consent until 90 days following the last dose of all study drugs.
- •Male subjects who are sexually active with a female of reproductive
- •potential must agree to use a condom from the time of informed consent
- •until 90 days following the last dose of all study drugs.
- •The following are examples of highly effective and additional methods of contraception:
- •Highly effective methods (must use one):
- •Hormonal associated with inhibition of ovulation (oral, injectable,
- •implantable, intravaginal, transdermal)
- 另有 9 项未显示
排除标准
- •3.2.1. Candidate for re-treatment with original platinum-based regimen
- •as second-line therapy.
- •3.2.2. Prior treatment with irinotecan, topotecan or dinutuximab.
- •3.2.3. Have active brain metastases. Subjects with brain metastases are
- •allowed if they completed definitive brain therapy, are asymptomatic and
- •radiologically stable, and if they are not currently receiving
- •corticosteroids or radiation. Subjects in whom steroids are being tapered
- •may be eligible with prior approval of the Medical Monitor.
- •3.2.4. Have mixed small-cell and non-small-cell histologic features.
- •3.2.5. Have a previous or concurrent cancer that is distinct in primary
- •site or histology from the cancer being evaluated in this study, except
- •cervical carcinoma in situ, treated basal cell carcinoma, superficial
- •bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer
- •curatively treated <3 years ago.
- •3.2.6. Have a history or current evidence of uncontrolled cardiovascular
- •disease including but not limited to the following conditions:
- •- Congestive heart failure of New York Heart Association (NYHA) grade
- •3 or greater.
- •- Unstable angina (symptoms of angina at rest) or new-onset angina
- •within 6 months.
- •- Arterial thrombosis, deep vein thrombosis, or pulmonary embolism
- •within 6 months.
- •- Myocardial infarction or stroke within 6 months.
- •- Pericarditis (any CTCAE v.4.03 grade), pericardial effusion (CTCAE
- •v4.03 Grade =2).
- •3.2.7. Have a history of atypical thrombotic thrombocytopenic purpura
- •(TTP) or hemolytic uremic syndrome (HUS).
- •3.2.8. Women who are pregnant or breast-feeding.
- •3.2.9. Have not recovered from prior surgery, significant trauma,
- •systemic anticancer therapy (e.g., chemotherapy, biologic therapy,
- •immunotherapy), radiation therapy or investigational therapy to Grade 1
- •or better toxicity prior to enrollment (Part 1) or randomization (Part 2).
- •3.2.10. Have had organ allograft or hematopoietic transplantation.
- •3.2.11. Known to be human immunodeficiency virus (HIV) positive.
- •3.2.12. Have an active infection requiring treatment or one that is
- •clinically serious in the Investigator's opinion.
- •3.2.13. Have received a live vaccine within 6 months of enrollment (Part
- •1) or randomization (Part 2).
- •3.2.14. Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong
- •CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization
- •3.2.15. Have any clinical condition that is considered unstable or might
- •jeopardize the safety of the subject and / or influence the subject's
- •compliance in the study.
研究者
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