NCT04258072

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 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

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	Vactosertib	Vactosertib: 50-mg white round film-coated tablets containing excipients (lactose monohydrate Fastflo 316, microcrystalline cellulose Avicel PH 102, crospovidone Kollidon CL-F, povidone Kollidon 30, magnesium stearate, opadry white) and active pharmaceutical ingredient (N-((4-(\[1,2,4\]triazolo\[1,5-a\]pyridin-6-yl)-5-(6-methylpyridin-2-yl)-1H-imidazol-2-yl)methyl)-2-fluoroaniline), 10% (w/w) of total weight

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2020-02-06
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea