Skip to content

A Phase I study of irinotecan, bevacizumab and TAS-102 for metastatic colorectal cancer patients

A Phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin - MODURATE

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180028
Enrollment
39
Registered
2019-01-22
Start date
2016-10-06
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

unresectable metastatic colorectal cancer

Interventions

Medication

Sponsors

Yamazaki Kentaro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed unresectable metastatic colorectal adenocarcinoma 2.Refractory to prior fluoropyrimidine and oxaliplatin therapy 3.No history of TAS-102, regorafenib and irinotecan therapy 4.Patient has measurable region 5.ECOG PS 0 or 1 6.Age 20<, <75 7.Patient has adequate organ function 8.Women of childbearing potential must have a negative pregnancy test 9.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Patient has serious illness or medical condition 2.Patient has had treatment with any of the following within the specified time frame prior to study drug administration a.Major surgery within prior 4 weeks b.Any anticancer drug therapy within prior 2 weeks c.Radiation within prior 2 weeks. 3.Patient has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapy 4.Pregnant or lactating female 5.Inappropriate for entry into this study in the judgment of the Investigator.

Design outcomes

Primary

MeasureTime frame
Dose limiting toxicity

Secondary

MeasureTime frame
Progression free survival, Time to treatment failure, Overall survival, Objective response rate, Disease control rate, Adverse event

Contacts

Public ContactHiroya Taniguchi

Aichi Cancer Center Hospital

h.taniguchi@aichi-cc.jp+81-52-762-6111

Outcome results

None listed

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