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

NCT04258072 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-06-15

No results posted yet for this study

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

Conditions

  • Pancreas Cancer

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-12-31
Completion
2023-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258072 on ClinicalTrials.gov