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

Associated Therapies: -

Clinical Trials

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

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

Interventions: Biological: Ipilimumab
Biological: Nivolumab
Drug: Regorafenib

First Posted Date: 2020-04-27

Last Posted Date: 2024-08-05

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 39

Registration Number: NCT04362839

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

Phase 2

Suspended

Conditions: Hepatocellular Carcinoma

Interventions: Device: TheraBionic
Drug: Regorafenib

First Posted Date: 2020-03-31

Last Posted Date: 2024-06-14

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 25

Registration Number: NCT04327700

Locations: 🇺🇸
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

Phase 1

Completed

Conditions: Advanced Refractory Solid Tumors

Interventions: Drug: CS1001
Drug: Regorafenib

First Posted Date: 2019-12-16

Last Posted Date: 2022-05-06

Lead Sponsor: CStone Pharmaceuticals

Target Recruit Count: 19

Registration Number: NCT04200404

Locations: 🇦🇺
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia

Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING)

Phase 1

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Regorafenib
Drug: Nivolumab

First Posted Date: 2019-11-20

Last Posted Date: 2023-12-29

Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Target Recruit Count: 69

Registration Number: NCT04170556

Locations: 🇪🇸
Hospital Vall d'Hebron, Barcelona, Spain
🇪🇸
Hospital Puerta de Hierro, Madrid, Spain
🇪🇸
Hospital Gregorio Marañon, Madrid, Spain

and more 4 locations

Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: BRAF V600E Negative
Metastatic Colorectal Adenocarcinoma
NRAS Gene Mutation Negative
KRAS Gene Mutation Negative
Stage IVA Colorectal Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Locally Advanced Unresectable Colorectal Adenocarcinoma
Stage III Colorectal Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8

Interventions: Biological: Cetuximab
Drug: Regorafenib
Drug: Irinotecan
Biological: Panitumumab

First Posted Date: 2019-10-07

Last Posted Date: 2024-02-07

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 22

Registration Number: NCT04117945

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

and more 12 locations