CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
Capecitabine/Cisplatin + Sorafenib +1 moredrug
Likely dose
Capecitabine/Cisplatin + Sorafenib 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01187212
NCT01187212Phase 2Completed

A Randomized Phase II Study of Capecitabine and Cisplatin (XP) +/- Sorafenib (Nexavar®) in Patients With Advanced Gastric Cancer

Asan Medical Center·interventional·Posted Aug 24, 2010·Updated Jan 7, 2020

In Brief

A Phase 2 clinical trial evaluating Capecitabine/Cisplatin + Sorafenib and Capecitabine/Cisplatin for Malignant Neoplasm of Stomach and Effects of Chemotherapy. Completed, enrolled 195 participants across 1 site.

Detailed Summary

This study investigates the efficacy and safety profiles of sorafenib in combination of capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced gastric cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.9 years ago

Interventions

Capecitabine/Cisplatin + Sorafenibdrug

Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing

Capecitabine/Cisplatindrug

Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1