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

A phase I open-label, non-randomized, dose-finding safety, tolerance and pharmacokinetic study of TSU-68 in combination with S-1 and oxaliplatin in patients with metastatic colorectal cancer.

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221365

Enrollment

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 cate

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: (1) Symptomatic brain metastasis. (2) Chronic nausea, vomiting or diarrhea considered to be clinically significant by the Investigator's opinion. (3) Known clinically significant interstitial lung disease or pulmonary fibrosis.

Design outcomes

Primary

Measure	Time frame
Safety (dose limiting toxicity) 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