GRAPE

A RANDOMIZED PHASE III STUDY OF TAS-118 VERSUS S-1 IN PATIENTS WITH GEMCITABINE-REFRACTORY ADVANCED PANCREATIC CANCER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222126

Enrollment

600

Registered

2013-06-26

Start date

2013-07-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

investigational material(s) Generic name etc : TAS-118 INN of investigational material : - Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
efficacy Overall survival	—

Secondary

Measure	Time frame
safety efficacy Progression free survival, Efficacy, Safety	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026