STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

April 30, 2027

Conditions
Colorectal Cancer Metastatic
Interventions
DRUG

standard second line treatment, at discretion of the investigator

Combination treatment may include: 5FU/LFA, capecitabine, oxaliplatin, irinotecan, bevacizumab, aflibercept

DRUG

Regorafenib (BAY73-4506)

"Regorafenib will be administered following a dose-escalation strategy: starting dose 80 mg/day orally with weekly escalation, per 40 mg increment up to 160 mg/day regorafenib); if no significant drug-related adverse events occurred for 21 days of a 28-day cycle. The following cycle will be administered at highest tolerated dose from cycle 1 (up to 160 mg), as per current guidelines and clinical practice.~Treatment will continue until disease progression, unacceptable toxic effects, motivated decision to stop the treatment by the treating physician, or refusal or withdrawal of consent by the patient.~Every cycle will be administered every 28 days (four weeks) +/- 3 days."

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER