NCT03692780撤回1 期
A Phase I Dose-Finding Followed by Phase IIa Randomized, Double-Blind, Placebo-Controlled, Parallel, Add-on to Cisplatin Plus Docetaxel Study to Evaluate the Safety, Tolerability and Efficacy Profiles of Careseng 1370 to Treat Chemotherapy-Induced Myelosuppression in Advanced Non-Small Cell Lung Cancer (NSCLC) Subjects
Careseng Biotech Co., Ltd.0 个研究点开始时间: 2019年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit
研究概览
简要总结
This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Of either gender aged at least 20 years old
- •Histologically or cytologically confirmed unresectable, locally advanced, metastatic untreated NSCLC and can be accurately assessed by computed tomography/magnetic resonance imaging (CT/MRI) scan (RECIST v1.1) for which regimen of cisplatin + docetaxel is arranged by the investigator; no prior chemotherapy treatment for this disease will be allowed.
- •ECOG performance status score ≤2 and life expectancy ≥12 months
- •Dated and signed informed consent
排除标准
- •Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit
- •Has undergone major surgery within 4 weeks before Screening visit
- •With contraindications to MRI
- •Has elective or planned surgery to be conducted during the trial
- •Has documented brain or leptomeningeal metastases or any cancer other than NSCLC
- •Inadequate hematologic function, as defined by: absolute neutrophil count (ANC) ≤ 1,500/µL; hemoglobin concentration < 10.0 g/dL; and platelet count ≤ 100,000/µL
- •Inadequate hepatic function, as defined by: total bilirubin level > ULN; AST or ALT > 1.5 x ULN; gamma-GT > 2.5 x ULN; ALP > 2.5 x ULN.
- •Inadequate renal function, as defined by: serum creatinine level > 1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) < 50 mL/min
- •Urinary protein >1+ on dipstick, edema or serum albumin < lower level of normal
- •Any other ≥ grade 3 laboratory abnormality at baseline
- •Inadequate coagulation function, as defined by: INR > 1.5 x ULN or aPTT > 1.5 x ULN
- •Male subject with female spouse/partners who are of childbearing potential refuses to adopt highly effective contraceptives from Screening visit until 7 days after end of study treatment
- •Female subjects with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating, refuses to adopt highly effective contraceptives, if heterosexually active, from Screening visit until 7 days after end of study treatment
- •Requirement of anticoagulants, antiplatelet treatments (e.g., warfarin, heparins) from Screening visit until Final visit
- •History of human immunodeficiency virus (HIV) infection
- •Has experienced any grade 3 or 4 gastrointestinal bleeding within 12 weeks before Screening visit
- •Has a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess <6 months before Screening visit, or the subject has a history of poorly controlled or recurrent inflammatory bowel disease (including Crohn's disease or ulcerative colitis)
- •Has participated in a clinical study within 4 weeks prior to Screening visit
- •Has a known allergy to investigational product Careseng 1370, matched placebo, cisplatin, docetaxel or their excipients. If there is suspicion that the subject may have an allergy, the subject should be excluded.
- •Has known alcohol or drug dependency
- •Requirement for ongoing immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine) or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days
- •Significant cardiovascular disease, including:
- •History of New York Heart Association (NYHA) class III or IV congestive heart failure
- •Ongoing uncontrolled hypertension
- •History of congenital long QT syndrome
- •Ongoing prolonged corrected QT (QTc) interval defined as at least 450 msec
- •History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
- •Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing per investigator's discretion
- •Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of cisplatin + docetaxel or Careseng 1370/matched placebo administration
- •Is not considered to be suitable for this study, in the opinion of the investigator
研究组 & 干预措施
Matched Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Careseng 1370
Experimental
干预措施: Careseng 1370 (Drug)
结局指标
主要结局
Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit
时间窗: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
End of Treatment will be Day 85
次要结局
- Maximum change and by visit change in white blood cell (WBC) count from baseline to post-treatment visits(Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Objective response rate (ORR) defined as the proportion of subjects with CR or PR as best overall response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results(Day 1, 43, 85)
- Proportion of subjects with anemia, neutropenia, or thrombocytopenia of all grades at post-treatment visits(Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Disease control rate (DCR) defined as the proportion of subjects with CR, PR, or SD as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results(Day 1, 43, 85)
- Maximum change and by visit change in red blood cell (RBC) count from baseline to post-treatment visits(Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Maximum change and by visit change in absolute neutrophil count (ANC) from baseline to post-treatment visits(Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Maximum change and by visit change in platelet count from baseline to post-treatment visits(Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Maximum change and by visit change in serum C-reactive protein (CRP) level from baseline to post-treatment visits(Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85)
- Proportion of subjects with complete response (CR), partial response (PR), stable disease (SD), and progression disease (PD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results(Day 1, 43, 85)
- Change in quality of life assessed by the Functional Assessment of Cancer Therapy Lung Cancer (FACT-L) total score from baseline to post-treatment visits(Day 1, 22, 43, 64, 85)
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