PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

June 15, 2025

Study Completion Date

December 15, 2025

Conditions
Colorectal Cancer
Interventions
DRUG

Regorafenib

"regorafenib administered until progression, unacceptable toxicity or patient's refusal followed after progression by panitumumab until further progression, unacceptable toxicity or patient's refusal in RAS and BRAF wt mCRC patients with the following characteristics:~1. previous treatment with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic agent (bevacizumab or aflibercept);~2. RECIST response or stable disease lasting at least 6 months to a previous first-line anti-EGFR-based treatment;~3. RAS and BRAF wt ct-DNA at the time of screening."

DRUG

Panitumumab

"panitumumab administered until progression, unacceptable toxicity or patient's refusal followed after progression by regorafenib until further progression, unacceptable toxicity or patient's refusal in RAS and BRAF wt mCRC patients with the following characteristics:~1. previous treatment with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic agent (bevacizumab or aflibercept);~2. RECIST response or stable disease lasting at least 6 months to a previous first-line anti-EGFR-based treatment;~3. RAS and BRAF wt ct-DNA at the time of screening."

Trial Locations (1)

56126

U.O. Oncologia 2 Universitaria, Pisa

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Amgen

INDUSTRY

lead

Gruppo Oncologico del Nord-Ovest

OTHER

NCT04787341 - PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence | Biotech Hunter | Biotech Hunter