A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

ovartis Pharma AG0 个研究点目标入组 490 人开始时间: 2021年8月23日最近更新: 2024年5月13日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma AG
入组人数: 490

研究概览入排标准研究者记录与标识符相似试验

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

•Participants eligible must meet all of the following criteria:
•1. signed ICF prior to study treatment
•2. age >= 18 years at the time of ICF
•3. histologically or cytologically confirmed mPDAC eligible for treatment in first line setting and not amenable for potentially curative surgery
•4. presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1
•5. ECOG performance status 0-1
•6. adequate organ function as defined by the following laboratory values:
•- ANC >= 1.5 x 10*9 /L
•- platelets >= 100 x 10*9/L
•- hemoglobin >= 9g /dL
•- calculated creatinine clearance >= 60 mL/min
•- albumin >= 3 g/dL
•- PT/INR and PTT <= 1.5 x ULN
•- total bilirubin <= 1.5 X ULN
•- AST and ALT <= 3.0 x ULN
•7. WCBP must have negative pregnancy test during screening and before starting study treatment
•8. able to adhere to study visit schedule and other protocol requirements
•9. must have recovered from treatment-related toxicities of prior anticancer therapies to grade <= 1 (CTCAE v 5.0), except alopecia
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 290

排除标准

•participants meeting any of the following criteria are not eligible for inclusion:
•1. previous systemic anti-cancer treatment for mPDAC
•2. pancreatic neuroendocrine (inslet) acinar or tumors
•3. known status of MSI-H or MMR-deficient pancreatic cancer
•4. presence of symptomatic CNS metastases, or CNS metastases that requires direct therapy or increasing doses of corticosteroids 2 weeks prior to study entry
•5. known history of severe allergy or hypersensitivity to any of the study drug or their excipients
•6. currently receiving any of the prohibited medications which cannot be discontinued within >= 7 days or 5 half-lifes, whichever is longer
•7. not recovered from a major surgery or has a major surgery within 4 weeks prior to start of the study
•8. radiation therapy or brain radiotherapy <= 4 weeks prior to study start
•9. impaired cardiac function or clinically significant cardio-vascular disease, such as:
•- congestive heart failure requiring treatment (NYHA grade >= 2), or clinically significant arrhythmia
•- acute myocardial infarction, unstable angina pectoris, coronary stenting or bypass surgery < 3 months prior to study entry
•- LVEF < 50%
•- elevated cardiac enzymes (troponin I) > 2 x ULN
•- cardiac valvulopathy >= grade 2
•- uncontrolled hypertension
•10. history of positive test for HIV infection
•11. active or chronic HBV or HCV infections (patients with a history of HCV infection must have been treated with confirmation of cure to be eligible)
•12. active untreated or uncontrolled systemic fungal, bacterial or viral infections
•13. use of hematopoietic growth factors or transfusion support <= 2 weeks prior to start the study
•14. conditions that are considered to have a high risk of clinically significant gastrointestinal track bleeding or any other condition associated with or history of significant bleeding
•15. serious, non-healing wounds
•16. pre-existing peripheral neuropathy > grade 1
•17. concurrent malignancy other than disease under treatment
•18. any significant medical condition, laboratory abnormality or psychiatric or social condition that would constitute unacceptable risk to the patients, contraindicate participation, limit patient's ability to comply with study requirements or compromise patient's compliance with the study protocol
•19. pregnant or breast-feeding woman
•20. WCBP, unless using highly effective method of contraception during and up to 90 days after the study drug treatment (NIS793)
•21. currently receiving other anti-cancer therapy or received other investigational product within 30 days or 5 half-lives prior to study treatment, whichever is longer

研究者

发起方

ovartis Pharma AG

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