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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019828

Enrollment

Registered

2015-12-15

Start date

2016-09-09

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 colorectal cancer

Interventions

TAS-102 25-35 (mg/m2) day1-5 CPT-11 150-180 (mg/m2) day 1 Bevacizumab 5 (mg/kg) day 1 every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven adenocarcinoma of unresectable colorectal cancer 2) Resistant or intolerant to fluoropyrimidine and oxaliplatin 3) No prior irinotecan, TAS-102 or regorafenib-containing chemotherapy 4) With measurable lesions according to RECIST version1.1 5) ECOG performance status of 0 or 1 6) 20<= and 75>= years old 7) Adequate organ function 8) No pregnancy 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Serious illness such as brain metastasis, systemic infection or gastrointestinal bleeding. 2) Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks. 3) Adverse events due to prior chemotherapy 4) Administration of blood transfusion or G-CSF within 2 weeks 5) Severe pulmonaly disorder 6) Thromboembolism (grade3 or higher) within 6 months 7) Inappropriate for the study in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Part1(dose-escalation): DLT between first 2 cycles Part2(expansion): the incidence of febrile neutropenia	—

Secondary

Measure	Time frame
Progression free survival Time to treatment failure Overall survival Objective response rate Disease control rate Safety	—

Countries

Japan

Contacts

Public ContactHiroya Taniguchi

Aichi Cancer Center Hospital Department of Clinical Oncology

h.taniguchi@aichi-cc.jp052-762-6111

Outcome results

None listed

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