NCT02200757已完成2 期
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 29
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years male or female.
- •Histological confirmation of SCLC.
- •Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
- •Capable of providing informed consent and complying with trial procedures.
- •Life expectancy >8 weeks.
- •Measurable tumor lesions according to RECIST 1.1 criteria.[22]
- •Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
- •Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
- •Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- •Accessibility to the site that ensures the subject will be able to keep all study-related appointments.
排除标准
- •Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
- •Prior treatment with topotecan.
- •Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.
- •Exposure to any investigational agent within 30 days of date of randomization.
- •Exposure to any systemic chemotherapy within 21 days of date of randomization.
- •Active (symptomatic) central nervous system (CNS) metastasis.
- •History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥3 years.
- •Laboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL.
- •Anion gap > 16 meq/L or arterial blood pH < 7.
- •Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D).
- •Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F).
- •Baseline QTc >470 msec measured by Fridericia's formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
- •History or signs of active coronary artery disease with angina pectoris within the last 6 months.
- •Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
- •Known history of HIV infection.
- •Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- •Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
- •Major surgery within 30 days prior to date of randomization.
- •Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- •Any condition that is unstable and could jeopardize the subject's participation in the study.
研究组 & 干预措施
Aldoxorubicin
Experimental
干预措施: Aldoxorubicin (Drug)
Topotecan
Active Comparator
干预措施: Topotecan (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 24 months
PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression. Progressive Disease is defined as: ≥20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥1 new lesion is also considered progression.
次要结局
- Number of Participants With Treatment-related Toxicities (Adverse Events)(Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs, up to 451 days.)
研究者
研究点 (29)
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