GRAPE

Phase 3

Completed

• Conditions: pancreatic cancer

• Registration Number: JPRN-jRCT2080222126
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

TAS-118 did not improve OS in patients with gemcitabine-refractory advanced pancreatic cancer compared to S-1. PFS and TTF were statistically significantly improved by TAS-118 compared with S-1. Incidence, profile and severity of adverse events were similar between groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-26
• Study Completion: 2017-04-28
• Results First Posted: 2018-11-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 603

Inclusion Criteria

Invasive pancreatic ductal carcinoma.
-Refractory to gemcitabine, and no post treatment after gemcitabine.
-Has evaluable metastatic lesion(s).
-Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
-Capable of oral intake.
-Written consent to participate as a subject in this clinical study.

Exclusion Criteria

-Unmanageable Diarrhea.
-Current or past severe lung disease.
-Any other active illness such as severe (e.g. grade 3 or higher) cardiac disease.
-The diabetic patients who have poorly controlled despite the medication or severe diabetic complication.
-Grade 3 or higher serious complications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified