A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Phase 3 Unknown 148 enrolled Samsung Pharmaceutical Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.

Timeline

Start: 2015-11
Primary completion: 2018-05
Completion: 2018-05

Publications

Jo JH, Kim YT, Choi HS, Kim HG, Lee HS, Choi YW, Kim DU, Lee KH, Kim EJ, Han JH, Lee SO, Park CH, Choi EK, Kim JW, Cho JY, Lee WJ, Moon HR, Park MS, Kim S, Song SY. Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial. Br J Cancer. 2024 Jan;130(1):43-52. doi: 10.1038/s41416-023-02474-w. Epub 2023 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TERTOMOTIDE	Vaccine	0.56 mg	Other
Background	Capecitabine	Small molecule	830 mg/m2	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Summary

Timeline

Publications

Drugs

Indications