Phase II study of TAS-102 in patients with metastatic colorectal cancer

A Phase II, MultiCenter, Randomized, Double-blind, Placebo-controlled Study of TAS-102 in Patients with Chemotherapy-Refractory Advanced Colorectal Cancer.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220849

Enrollment

162

Registered

2009-09-08

Start date

2009-09-08

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

Patients with non- resectable advanced metastatic colorectal cancer refractory or intolerable to fluoropyrimidine, irinotecan and oxaliplatin, who had a history of chemotherapy of 2 or more regimens.

Interventions

investigational material(s) Generic name etc : TAS-102 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with colorecotal cancer, who had received prior therapy, at least two regimens, containing fluoropyrimidine, oxaliplatin, and irinotecan 2)Patients must be able to take orally

Exclusion criteria

Exclusion criteria: 1)Patient who has serious concomitant disease 2)Patient who had received TAS-102

Design outcomes

Primary

Measure	Time frame
Overall survival To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer	—

Secondary

Measure	Time frame
Response rate, Disease control rate, Progression free survival, Profile and tolerability of adverse events RECIST ver.1.0,CTCAE ver.3.0	—

Outcome results

None listed

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