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Phase I/II trial of YHI-1003 plus Capecitabine

Phase I/II trial of YHI-1003 plus Capecitabine in Patients with Refractory Advanced Colorectal Cancer

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221670
Enrollment
50
Registered
2011-12-13
Start date
2011-12-13
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

Refractory Advanced Colorectal Cancer

Interventions

Sponsors

Yakult Honsha Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with recurrent or metastatic colorectal cancer (2)Patients must have failed available therapy for the treatment of advanced colorectal cancer. (3)No prior exposure to capecitabine and S-1 (4)ECOG performance status (PS) :0-1

Exclusion criteria

Exclusion criteria: (1)Patients with uncontrolled intercurrent illness (2)Female patients who are pregnant or lactating (3)Patients with known central nervous system CNS metastases

Design outcomes

Primary

MeasureTime frame
safety CTCAE v4.0

Secondary

MeasureTime frame
efficacy and pharmacokinetic profile RECIST ver1.1

Outcome results

None listed

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