Pancreas Cancer Clinical Trial
Official title:
Phase 1b Study of Vactosertib (TEW-7197) in Combination With Nal-IRI／FL in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed First-Line Gemcitabine／Nab-Paclitaxel
To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel
- Number of patients : Total 24 patients (6-12 patients in phase 1 part and 12 patients in expansion cohort ) - Treatment : - Vactosertib* 100-300 mg bid for 5 days - Liposomal Irinotecan (Onivyde) 70mg/m2 on D1 - LV 200mg/m2 IV bolus on D1 - 5-FU 2400mg/m2 CIV over 46 hours on D1 - Vactosertib will be kindly provided by MedPacto. - Disease evaluation: Tumor assessment will be conducted at screening and before Day 1 of every third cycle starting with Cycle 4 - Period : Approximately 24 months from the date of Institutional Review Board (IRB) approval - Primary endpoint : To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel - Secondary endpoint : - Progression-Free Survival (PFS) (RECIST 1.1 criteria) - Overall Survival (OS) - Objective Response Rate (ORR) (RECIST 1.1 criteria) - Disease Control Rate (DCR) (RECIST 1.1 criteria) - Exploratory endpoint - Pharmacokinetic assessment: before treatment, post treatment 1.5h, 4.5h, and 8hPharmacodynamic assessment: to evaluate changes in the amount of p-SMAD in PBMC. - Biomarker analysis in pre-treated and post-treated tumor samples ;
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