Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study (PC(UR-M) GEM/nab-PTX + MK615)

FUKUBA Nobuhiko0 个研究点目标入组 35 人开始时间: 2019年3月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1)Histopathologically confirmed pancreatic cancer (adenocarcinoma and
•adenosquamous carcinoma)
•(2)Not resectable metastatic pancreatic cancer
•(3)With measurable lesions by RECIST ver 1.1
•(4)No prior chemo-, immune-, radiotherapy
•(5)ECOG performance status of 0 or 1
•(6)20-80 years old
•(7)Expected survival period is more than 3 months
•(8)The organ function must be kept within 14 days before registration
•leukocyte >= 3,000/mcL , neutrophil >=1,500/mcL , platelet >=75,000/mcL, hemoglobin >=10.0 g/dL, T-Bilirubin >=2.0 mg/dL, AST =<100 IU/L (AST = <300 IU/L with liver metastasis or biliary drainage), ALT =<100 IU/L (ALT =<300 I U/L with liver metastasis or biliary drainage), serum creatinine =<1.5 mg/dL
•(9)written informed consent got from the patient

•(1)Active concomitant malignancy or history of another malignancy within the last 5years
•(2)Symptomatic brain metastasis
•(3)Severe infectious diseases
•(4)Subjects with the past history of Interstitial pneumonia or pulmonary fibrosis
•(5)Subjects with the past history of severe heart disease
•(6)Severe Paresthesia or Sensory disorder with motor dysfunction
•(7)Severe pleural effusion, ascites, or pericardial effusion
•(8)Subjects with the past history of severe diseases (kidney disease,liver disease, heart disease).
•(9)History of Radiation therapy for pancreatic cancer
•(10)Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
•(11)Inappropriate to be enrolled in this study judged by the investigators

发起方

FUKUBA Nobuhiko