A phase II study of TSU-68 in patient with metastatic colorectal cancer

A phase II open label randomized multicenter trial of TSU-68 in combination with S-1 and oxaliplatin versus S-1 in combination with oxaliplatin in patients with metastatic colorectal cancer.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221366

Enrollment

100

Registered

2011-01-25

Start date

2011-01-25

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

Metastatic colorectal cancer

Interventions

investigational material(s) Generic name etc : TSU-68, S-1, Oxaliplatin INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin Therapeutic categ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Signed, written informed consent. (2) Histologically or cytologically confirmed CRC. (3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

Exclusion criteria: (1) Brain metastasis or leptomeningeal metastasis confirmed by imaging study, or suspected brain metastasis. (2) Presence of active infection. (3) Known clinically significant interstitial lung disease or pulmonary fibrosis.

Design outcomes

Primary

Measure	Time frame
Progression free survival RECIST (ver. 1.1)	—

Secondary

Measure	Time frame
Overall response rate, Overall survival, Safety CTCAE (ver. 4.0)	—

Outcome results

None listed

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