NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041180028

Registered date:22/01/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedunresectable metastatic colorectal cancer
Date of first enrollment06/10/2016
Target sample size39
Countries of recruitment
Study typeInterventional
Intervention(s)Medication

Outcome(s)

Primary OutcomeDose limiting toxicity
Secondary OutcomeProgression free survival, Time to treatment failure, Overall survival, Objective response rate, Disease control rate, Adverse event

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1.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
Exclude criteria1.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.

Related Information

Contact

Public contact
Name Hiroya Taniguchi
Address 1-1 Kanokoden, Chikusa-ku Nagoya,Aichi Aichi Japan 464-8681
Telephone +81-52-762-6111
E-mail h.taniguchi@aichi-cc.jp
Affiliation Aichi Cancer Center Hospital
Scientific contact
Name Kentaro Yamazaki
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail k.yamazaki@scchr.jp
Affiliation Shizuoka Cancer Center