NCT03880877

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

Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated According to UGT1A1 Genotyping Versus Regorafenib Monotherapy in Patients With Previously Treated Metastatic Colorectal Cancer: A Prospective, Randomized, Controlled Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Primary objective: Progression-free survival Secondary objective: Overall survival, best objective response, disease control rate, time to progression, duration of treatment and adverse events Number of Subjects: 153 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting. Plan of the Study: 1. This is a prospective, multicenter, randomized in a 2:1 ratio, controlled study. 2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 4 years. 3. Duration of Treatment: Treatment was administered until disease progressed.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-02-26
• Primary completion: 2021-03-01
• Completion: 2021-12-31
• First posted: 2019-03-19
• Last updated: 2019-03-21

Locations

1 site across 1 country: Taiwan