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Regorafenib

Phase 2

Colorectal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: May 20, 2026

Target and mechanism

Molecular targetDDR2, EPHA2, FGFR2, MAPK11, PDGFRB, PDGFRA, BRAF, KIT, TEK, FGFR1, NTRK1, RAF1, ABL1, FRK, RET, FLT1, FLT4, KDR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment214

FDA Designations

No designations recorded

Clinical trial landscape

Regorafenib · 1 trial · 1 indication

Phase 2 1
NCT04787341PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse SequenceColorectal Cancer
ACTIVE NOT_RECRUITING214 Analytics
PHASE2ACTIVE NOT_RECRUITING
PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival
30 months

time from randomization to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

Secondary Endpoints

Overall Toxicity Rate
24 months
G3/4 Toxicity Rate
24 months
1st-Progression free survival
21 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panitumumab followed by RegorafenibACTIVE_COMPARATOR -
Regorafenib followed by PanitumumabEXPERIMENTAL -

Interventions

NameTypeDescription
RegorafenibDRUGregorafenib 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.
PanitumumabDRUGpanitumumab 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age ≥ 18 years. * Written informed consent to molecular analyses. * Histologically proven diagnosis of CRC. * At least one measurable lesion according to RECIST1.1 * ECOG PS ≤ 1. * mCRC previously treated for metastatic disease with, or not considered candidates for, fluoropyr...

Countries:Italy
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT04787341studyFirstPostDate: changed

Frequently asked questions about Regorafenib

What is Regorafenib used for in Colorectal Cancer?

Regorafenib is an investigational small molecule being studied for the treatment of Colorectal Cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in a clinical trial involving patients with this condition.

What does Regorafenib target?

Regorafenib is a kinase inhibitor that targets multiple proteins, including DDR2, EPHA2, FGFR2, MAPK11, PDGFRB, PDGFRA, BRAF, KIT, TEK, FGFR1, NTRK1, RAF1, ABL1, FRK, RET, FLT1, FLT4, and KDR. By inhibiting these targets, it may interfere with cancer cell growth and survival.

Who is developing Regorafenib?

Regorafenib is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 2 clinical development for Colorectal Cancer.

What phase is Regorafenib in?

Regorafenib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is active but not recruiting participants, with a planned enrollment of 214 patients.

What clinical trials is Regorafenib in?

Regorafenib is being studied in a Phase 2 clinical trial with the identifier NCT04787341. The trial is titled "PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence" and is being conducted in Italy. It enrolls adults aged 18 years and older with Colorectal Cancer.

Is Regorafenib the same as any other drug?

Regorafenib is also known by the ChEMBL identifier CHEMBL1946170. This identifier is used in chemical databases to reference the compound. The drug is being investigated under this name in research and clinical contexts.