Phase 1 study of CS-7017 in combination with FOLFIRI

Phase 1 study of CS-7017 in combination with FOLFIRI in subjects with Metastatic colorectal cancer(CRC)who failed First-line therapy

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221193

Enrollment

Registered

2010-08-09

Start date

2010-08-09

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 CRC who failed First-line therapy

Interventions

investigational material(s) Generic name etc : CS-7017 INN of investigational material : efatutazone Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Histologically or cytologically diagnosed CRC. -Metastatic CRC who failed First-line therapy. -Measurable disease(RECIST Ver.1.1). -Male or female>=20 years of age. -ECOG performance status: 0-1. etc.

Exclusion criteria

Exclusion criteria: -First-line treatment with an CPT-11-based regimen. -History of any of the following events within 6 months prior to start of study treatment myocardial infraction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or cerebral infraction, pulumonary embolizm, deep vein thrombosis, or other clinically significant thromboembolic event, clinically significant pulmonary disease (eg severe COPD or asthma) -Patient with a clinically active brain metastasis, or who need drugs to control adverse event like edema and pleural effusion -Diarrhea, inflammatory bowel disease, or bow obstruction etc.

Design outcomes

Primary

Measure	Time frame
Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol	—

Secondary

Measure	Time frame
-Determination of the recommended dose -Preliminary anti-tumor effect of CS-7017/FOLFIRI -Preliminary biomarker study of CS-7017 -To study potential biomarker of CS-7017 activity according to the protocol -To evaluate anti-tumor effect according to RECIST	—

Outcome results

None listed

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