Vactosertib With Nal-IRI/FL in Metastatic Pancreatic Ductal Adenocarcinoma.

Summary

Participation Requirements

Description

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 pro...

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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