2024-516336-97-00招募中2 期
“NALPAC” A NON-COMPARATIVE RANDOMIZED PHASE 2 STUDY, EVALUATING THE EFFICACY OF 5-FU + NALIRI AND 5-FU + NALIRINOX FOR METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (PDAC), PROGRESSIVE AFTER GEMCITABINE-ABRAXANE OR GEMCITABINE MONOTHERAPY.
Groupe Belge D'Oncologie Digestive12 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2024年9月11日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 12
- 主要终点
- PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).
研究概览
简要总结
Progression-free-survival rate (PFSR) at day 85
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven metastatic adenocarcinoma of the pancreas
- •Effective contraception for both male and female patients if the risk of conception exists
- •Peripheral Neuropathy < grade 2
- •Progression documented after first line treatment with Gemcitabine-Abraxane or gemcitabine alone
- •Signed written informed consent
- •ECOG PS 0/1 at study entry
- •Measurable disease
- •Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
- •INR/PTT ≤ 1.5x ULN
- •Life expectancy of at least 12 weeks
排除标准
- •Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- •Complete DPD deficiency
- •Liver failure, cirrhosis Child Pugh B or C
- •Active chronic hepatitis B or C with a need for antiviral treatment
- •Brain metastasis
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
- •History of organ allograft
- •Ongoing uncontrolled, serious infection
- •Renal failure requiring dialysis
- •Patients receiving or having received any investigational treatment within 4 weeks prior to the first dose of treatment, or participating to another clinical study
- •The following drugs are noted as interacting with Pegylated liposomal irinotecan (in combination with 5-FU and LV, in patients who have progressed following gemcitabine-based therapy), and are therefore excluded from the study: Live or live-attenuated vaccines in patients immunocompromised by chemotherapy, strong CYP3A4 inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John’s wort. Strong CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole and ketoconazole). Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy. Strong UGT1A1 inhibitors (e.g. atazanavir, gemfibrozil, indinavir, regorafenib)
- •History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
- •Known hypersensitivity to any of the components of study treatments
- •Previous malignancy in the last past 3 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or carcinoma in situ of any type
- •Pregnancy or breast feeding
- •Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
- •Unstable angina, congestive heart failure ≥NYHA class II
- •Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg
- •HIV infection
结局指标
主要结局
PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).
PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).
次要结局
- Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination
- PFS and sensitivity analysis
- Objective tumor response according to RECIST v 1.1
- Overall survival
- Disease control
- Duration of response
- Exploratory endpoint: Translational analysis on tumor tissue and blood samples
研究者
Prof. Dr. Ivan Borbath
Scientific
Groupe Belge D'Oncologie Digestive
研究点 (12)
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