Regorafenib

Generic Name: Regorafenib

Brand Names: Stivarga

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₅ClF_₄N_₄O_₃

CAS Number: 755037-03-7

Unique Ingredient Identifier: 24T2A1DOYB

Background: Regorafenib is an orally-administered inhibitor of multiple kinases. It is used for the treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumours, and hepatocellular carcinoma. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017.

Indication: Regorafenib is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Regorafenib is also indicated for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.

Associated Conditions: Hepatocellular Carcinoma, Metastatic Colorectal Cancer (CRC), Metastatic Gastrointestinal Stromal Tumor (GIST), Locally advanced Gastrointestinal stromal tumor, Unresectable Gastrointestinal stromal tumor

Clinical Trials

Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients

Phase 1

Active, not recruiting

Conditions: Glioblastoma, IDH-wildtype
MGMT-Methylated Glioblastoma

Interventions: Drug: Regorafenib
Drug: Temozolomide

First Posted Date: 2023-10-23

Last Posted Date: 2024-12-24

Lead Sponsor: Istituto Oncologico Veneto IRCCS

Target Recruit Count: 36

Registration Number: NCT06095375

Locations: 🇮🇹
Istituto Oncologico Veneto IRCCS, Padova, Italy
🇮🇹
Humanitas Research Hospital, Rozzano, Italy

A Study of JMT101 in Patients With Metastatic Colorectal Cancer

Phase 2

Not yet recruiting

Conditions: Metastatic Colorectal Cancer (mCRC)

Interventions: Drug: JMT101
Drug: Regorafenib (Stivarga)
Drug: SG001
Drug: Irinotecan

First Posted Date: 2023-10-18

Last Posted Date: 2023-10-18

Lead Sponsor: Shanghai JMT-Bio Inc.

Target Recruit Count: 102

Registration Number: NCT06089330

Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation and SDHB Deficient GIST) in the Post-imatinib Second-line Setting.

Phase 2

Recruiting

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: Regorafenib

First Posted Date: 2023-10-17

Last Posted Date: 2025-01-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT06087263

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Safety and Efficacy of NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

Phase 1

Recruiting

Conditions: Glioblastoma, IDH-wildtype
Head and Neck Squamous Cell Carcinoma
Melanoma
Merkel Cell Carcinoma
Mismatch Repair Deficient Solid Malignant Tumor
Microsatellite Instability-High Colorectal Cancer
Colorectal Cancer
Microsatellite Instability-High Solid Malignant Tumor
Non-small Cell Lung Cancer
Renal Cell Carcinoma

Interventions: Drug: NEO212 Oral Capsule
Drug: FOLFIRI Protocol
Drug: Ipilimumab
Drug: Regorafenib
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Bevacizumab
Drug: Nivolumab

First Posted Date: 2023-09-21

Last Posted Date: 2024-10-16

Lead Sponsor: Neonc Technologies, Inc.

Target Recruit Count: 134

Registration Number: NCT06047379

Locations: 🇺🇸
Precision NextGen Oncology, Beverly Hills, California, United States
🇺🇸
Northwest Medical Specialties, Tacoma, Washington, United States

An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

First Posted Date: 2023-09-08

Last Posted Date: 2025-02-26

Lead Sponsor: Bayer

Target Recruit Count: 2326

Registration Number: NCT06029010

Locations: 🇺🇸
Many Locations, Multiple Locations, New Jersey, United States

Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer

Phase 2

Recruiting

Conditions: MSI-H Colorectal Cancer

Interventions: Drug: Regorafenib
Drug: Pembrolizumab

First Posted Date: 2023-08-23

Last Posted Date: 2025-04-30

Lead Sponsor: Ibrahim Halil Sahin

Target Recruit Count: 154

Registration Number: NCT06006923

Locations: 🇺🇸
City of Hope, Irvine, California, United States
🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States

and more 2 locations