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

JRCT ID: jRCTs041180028

Registered date:22/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: unresectable metastatic colorectal cancer
• Date of first enrollment: 06/10/2016
• Target sample size: 39
• Study type: Interventional
• Intervention(s): Medication

Outcome(s)

• Primary Outcome: Dose limiting toxicity
• Secondary Outcome: Progression 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
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yamazaki Kentaro
• Source(s) of Monetary Support: Taiho pharmaceutical CO., LTD.