A phase I study of TAS-102 and irinotecan

A phase I study of TAS-102 and irinotecan in patients with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222053

Enrollment

Registered

2013-03-29

Start date

2013-03-29

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 metastatic colorectal cancer

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 histologically confirmed metastatic colorectal cancer 2) Patients can be administered orally 3) Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1 4) Patients without prior irinotecan based chemotherapy

Exclusion criteria

Exclusion criteria: 1) Patient who has serious concomitant disease

Design outcomes

Primary

Measure	Time frame
Safety CTCAE (ver.3.0)	—

Secondary

Measure	Time frame
Pharmacokinetics, Efficacy RECIST (ver.1.0)	—

Outcome results

None listed

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