Careseng 1370 for Chemotherapy-Induced Myelosuppression

赞助:

合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

September 25, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

March 2019

预计主要完成日期

March 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit[ Time Frame: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 ]

End of Treatment will be Day 85

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Proportion of subjects with anemia, neutropenia, or thrombocytopenia of all grades at post-treatment visits[ Time Frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 ]
Maximum change and by visit change in white blood cell (WBC) count from baseline to post-treatment visits[ Time Frame: 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[ Time Frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 ]
Maximum change and by visit change in red blood cell (RBC) count from baseline to post-treatment visits[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: Day 1, 43, 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[ Time Frame: Day 1, 43, 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[ Time Frame: 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[ Time Frame: Day 1, 22, 43, 64, 85 ]
FACT-L total score ranges from 0 to 144. Higher values represent a worse outcome

描述性信息

简略标题 ^ICMJE

Careseng 1370 for Chemotherapy-Induced Myelosuppression

正式标题 ^ICMJE

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

简要概况

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.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 1/Phase 2

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Careseng 1370
4,000mg granules in sachet
Drug: Placebo
4,000mg granules in sachet

研究工具

Experimental: Careseng 1370
Placebo Comparator: Matched Placebo

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

June 2021

预计主要完成日期

March 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Of either gender aged at least 20 years old 2. 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. 3. ECOG performance status score ≤2 and life expectancy ≥12 months 4. Dated and signed informed consent Exclusion Criteria: 1. Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit 2. Has undergone major surgery within 4 weeks before Screening visit 3. With contraindications to MRI 4. Has elective or planned surgery to be conducted during the trial 5. Has documented brain or leptomeningeal metastases or any cancer other than NSCLC 6. 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 7. 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. 8. Inadequate renal function, as defined by: serum creatinine level > 1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) < 50 mL/min 9. Urinary protein >1+ on dipstick, edema or serum albumin < lower level of normal 10. Any other ≥ grade 3 laboratory abnormality at baseline 11. Inadequate coagulation function, as defined by: INR > 1.5 x ULN or aPTT > 1.5 x ULN 12. 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 13. 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 14. Requirement of anticoagulants, antiplatelet treatments (e.g., warfarin, heparins) from Screening visit until Final visit 15. History of human immunodeficiency virus (HIV) infection 16. Has experienced any grade 3 or 4 gastrointestinal bleeding within 12 weeks before Screening visit 17. 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) 18. Has participated in a clinical study within 4 weeks prior to Screening visit 19. 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. 20. Has known alcohol or drug dependency 21. 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 22. Significant cardiovascular disease, including: 1. History of New York Heart Association (NYHA) class III or IV congestive heart failure 2. Ongoing uncontrolled hypertension 3. History of congenital long QT syndrome 4. Ongoing prolonged corrected QT (QTc) interval defined as at least 450 msec 5. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) 23. Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing per investigator's discretion 24. 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 25. Is not considered to be suitable for this study, in the opinion of the investigator

性别

参与研究的性别:

All

年龄

最小年龄：20 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Careseng Biotech Co., Ltd.

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名