NCT03913455已完成2 期
A Phase II Study Evaluating Efficacy and Safety of Hypomethylating Agent Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer
Shadia Jalal, MD4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年6月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a phase II, open-label, single arm, single-stage study. Both, chemo-sensitive and chemo-resistant patients will be enrolled and treated with 4 cycles of combination of Guadecitabine and carboplatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female subjects, age ≥ 18 years.
- •Histological or cytological diagnosis of small cell lung cancer. Subjects must have extensive-stage disease is defined as disease beyond the ipsilateral hemithorax, mediastinum and ipsilateral supraclavicular area and including malignant pleural or pericardial effusion or hematogenous metastases.
- •Patient should not have received more than 1 prior line of chemotherapy (could have received immunotherapy which does not count as chemotherapy).
- •ECOG PS 0-1
- •Measurable disease as per RECIST v1.
- •Subjects may have bone-only disease. NOTE: Bone-only subjects are eligible if their disease can be documented/evaluated by bone scans, CT or MRI. Their disease will be assessed using MD Anderson criteria. NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation.
- •Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:
- •Hemoglobin ≥ 9.0 g/dL
- •Absolute neutrophil count (ANC) ≥ 1,500/mm3
- •Platelet count ≥ 100,000/mm3
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN). For subjects with Gilbert's Disease, total bilirubin ≤ 3 x ULN
- •ALT and AST ≤ 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤ 5×ULN
- •International Normalized Ratio (INR) ≤1.5, if not therapeutically anticoagulated. Subjects who are being therapeutically anticoagulated may be included provided that the anticoagulation regimen is stable and closely monitored.
- •Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute/1.73 m2 as determined using the Cockcroft-Gault formula.
- •Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.
- •Male and female subjects of child- bearing potential must agree to use an effective method of birth control from the screening visit through 6 months after the last dose of study drug.
排除标准
- •Platinum refractory disease defined as disease progression during first line platinum containing chemotherapy regimen. Progression following platinum based therapy is allowed.
- •Prior therapy with a hypomethylating agent.
- •Previously untreated (non-irradiated), symptomatic brain metastases. No prior treatment is required for non-symptomatic brain metastases. Previously treated symptomatic brain metastases are permitted.
- •Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
- •Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.)
- •Hypersensitivity to (IMP) or components of the study treatment regimen.
- •Treated with any investigational drug within 3 weeks of first dose of study treatment.
- •Pregnant or breastfeeding.
- •Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.
研究组 & 干预措施
Guadecitabine and Carboplatin
Other
Each cycle = 28 days; Subjects receive 4 cycles
干预措施: Guadecitabine (Drug)
Guadecitabine and Carboplatin
Other
Each cycle = 28 days; Subjects receive 4 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 7 months.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.
次要结局
- Objective Response Rate (ORR)(Up to a maximum of 7 months)
- Disease Control Rate (DCR)(Up to a maximum of 7 months)
- Adverse Events(AEs had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 5 months)
- Overall Survival (OS)(Time of treatment start until death or date of last contact, up to a maximum of 16 months.)
研究者
Shadia Jalal, MD
Sponsor-Investigator
Hoosier Cancer Research Network
研究点 (4)
Loading locations...
相似试验
终止
2 期
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLCCarcinoma, Non-Small-Cell LungNon-Small Cell Lung CarcinomaNonsmall Cell Lung CancerNon Small Cell Lung CancerNon-Small Cell Lung CancerNCT04984811NeoImmuneTech33
尚未招募
2 期
Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRCAdvanced/Metastatic Colorectal CancerNCT06322563Tianjin Medical University Cancer Institute and Hospital20
已完成
2 期
Safety and Efficacy Study of Panzem NCD to Treat GlioblastomaRecurrent Glioblastoma MultiformeNCT00306618CASI Pharmaceuticals, Inc.27
尚未招募
1 期
Phase II Clinical Study of LTC004 in Patients With Advanced SarcomaUnresectable or Metastatic SarcomaNCT06384248Letolab30
进行中（未招募）
2 期
A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Maintenance Therapy for ES-SCLCLung Cancer, Small CellNCT05228496Zhejiang Cancer Hospital21