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Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated in Patients With Previously Treated Metastatic Colorectal Cancer

NCT03880877 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-03-21

No results posted yet for this study

Summary

A prospective, multicenter, randomized in a 2:1 ratio, controlled, clinical trial with two parallel arms will be conducted to compare irinotecan dose escalated FOLFIRI according to UGT1A1 genotyping plus 120 mg regorafenib with 120 mg regorafenib alone in previously treated patients with metastatic colorectal cancer (mCRC).

Conditions

Interventions

DRUG

Regorafenib

Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle

GENETIC

UGT1A1 genotyping (TA6/TA6)

The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2

GENETIC

UGT1A1 genotyping (TA6/TA7)

The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2

GENETIC

UGT1A1 genotyping (TA7/TA7)

The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2

DRUG

Leucovorin and 5-FU

Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period)

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Jaw-Yuan Wang, PhD · Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2021-03-01
Completion
2021-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880877 on ClinicalTrials.gov