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

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Phase 1

Recruiting

Conditions: Rhabdomyosarcoma

Interventions: Radiation: radiotherapy
Drug: Irinotecan
Drug: Vinorelbine
Drug: Actinomycin D
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Ifosfamide
Drug: Temozolomide
Drug: Regorafenib
Drug: Vincristine

First Posted Date: 2020-11-12

Last Posted Date: 2024-05-23

Lead Sponsor: University of Birmingham

Target Recruit Count: 1672

Registration Number: NCT04625907

Locations: 🇬🇷
University Unit of Pediatric Oncology-hematology - Children's Hospital Agia Sophia, Athens, Greece
🇮🇱
Rambam Health Care Campus, Haifa, Israel
🇮🇱
Hadassah University Medical Centre, Jerusalem, Israel

and more 125 locations

Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colo-rectal Cancer
Metastatic Cancer

Interventions: Drug: Regorafenib
Drug: Cyclophosphamide
Drug: Capecitabine
Drug: Aspirin

First Posted Date: 2020-09-01

Last Posted Date: 2024-12-20

Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Target Recruit Count: 49

Registration Number: NCT04534218

Locations: 🇫🇷
Hôpital Nord Franche-Comté, Montbéliard, France
🇫🇷
CHU de Besançon, Besançon, France
🇫🇷
Centre georges-François Leclerc, Dijon, France

Neoadjuvant Regorafenib in Combination with Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer

Phase 2

Recruiting

Conditions: Rectal Cancer Stage III
Rectal Cancer Stage II

Interventions: Drug: Nivolumab 10 MG/ML Intravenous Solution
Drug: Regorafenib 30 MG Oral Tablet
Radiation: Radiotherapy
Procedure: Surgery
Procedure: Non-operative Management

First Posted Date: 2020-08-07

Last Posted Date: 2025-03-05

Lead Sponsor: Jules Bordet Institute

Target Recruit Count: 72

Registration Number: NCT04503694

Locations: 🇧🇪
UZ Gent, Gent, Belgium
🇧🇪
Institut Jules Bordet, Anderlecht, Belgium
🇧🇪
Erasme, Brussels, Belgium

and more 7 locations

Optimization for Regorafenib in HCC

Phase 2

Terminated

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Regorafenib 40 MG

First Posted Date: 2020-07-20

Last Posted Date: 2021-12-30

Lead Sponsor: SC Liver Research Consortium, LLC

Target Recruit Count: 7

Registration Number: NCT04476329

Locations: 🇺🇸
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
🇺🇸
Tulane University, New Orleans, Louisiana, United States
🇺🇸
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States

and more 6 locations

Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Trifluridine/Tipiracil then Regorafenib
Drug: Regorafenib then Trifluridine/Tipiracil

First Posted Date: 2020-06-30

Last Posted Date: 2025-03-30

Lead Sponsor: UNICANCER

Target Recruit Count: 234

Registration Number: NCT04450836

Locations: 🇫🇷
Centre hospitalier d'Auxerre, Auxerre, France
🇫🇷
Infirmerie Protestante de Lyon, Caluire-et-Cuire, France
🇫🇷
Centre Antoine Lacassagne, Nice, France

and more 33 locations

Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

Conditions: Colorectal Cancer

Interventions: Drug: Regorafenib
Drug: Fruquintinib

First Posted Date: 2020-06-16

Last Posted Date: 2020-06-16

Lead Sponsor: Peking University

Target Recruit Count: 268

Registration Number: NCT04431791

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China

Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Colorectal Carcinoma
Stage IV Rectal Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Metastatic Rectal Adenocarcinoma
Stage IIIA Colon Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Advanced Colon Adenocarcinoma
Metastatic Colon Adenocarcinoma