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

Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)
Biological: Nivolumab (Opdivo)

First Posted Date: 2019-10-15

Last Posted Date: 2023-07-18

Lead Sponsor: Bayer

Target Recruit Count: 70

Registration Number: NCT04126733

Locations: 🇺🇸
Northwest Cancer Specialists, PC, Vancouver, Washington, United States
🇺🇸
Minnesota Oncology Hematology, PA, Minneapolis, Minnesota, United States
🇺🇸
Baylor Charles A. Sammons Cancer Center at Dallas, Dallas, Texas, United States

and more 12 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

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.

Phase 2

Recruiting

Conditions: Malignant Solid Tumor

Interventions: Drug: Cabozantinib
Drug: Trametinib
Drug: HDM201
Drug: Regorafenib
Drug: Alectinib
Drug: Avapritinib
Drug: Ribociclib
Drug: Dabrafenib

First Posted Date: 2019-10-04

Last Posted Date: 2024-12-12

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 455

Registration Number: NCT04116541

Locations: 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
Institut Paoli Calmettes, Marseille, France

and more 5 locations

Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Phase 1

Conditions: Colorectal Cancer
Immunotherapy

Interventions: Drug: Regorafenib and PD-1 inhibitor

First Posted Date: 2019-10-01

Last Posted Date: 2020-12-30

Lead Sponsor: Shanghai Changzheng Hospital

Target Recruit Count: 120

Registration Number: NCT04110093

Locations: 🇨🇳
Department of Medical Oncology, Shanghai Changzheng Hospital, Shanghai, China

Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

Not Applicable

Recruiting

Conditions: Leiomyosarcoma
Bone Sarcoma
Osteosarcoma
Chondrosarcoma
Undifferentiated Pleomorphic Sarcoma
Ewing Sarcoma
Angiosarcoma

Interventions: Drug: Treatment by Placebo
Drug: Treatment by Regorafenib

First Posted Date: 2019-08-13

Last Posted Date: 2023-08-08

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 168

Registration Number: NCT04055220

Locations: 🇫🇷
Hôpital Jean Minjoz, Besançon, France
🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Centre Oscar Lambret, Lille, France

and more 13 locations

Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma

Phase 2

Active, not recruiting

Conditions: Recurrent Glioblastoma

Interventions: Drug: Regorafenib

First Posted Date: 2019-08-09

Last Posted Date: 2024-12-05

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 14

Registration Number: NCT04051606

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Regorafenib and PD-1 Antibody in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer

Phase 2

Recruiting

Conditions: MSS
Colorectal Cancer Metastatic

Interventions: Drug: Regorafenib and PD-1 antibody in Combination with Radiotherapy
Radiation: Radiation therapy

First Posted Date: 2019-07-23

Last Posted Date: 2023-03-23

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 28

Registration Number: NCT04030260

Locations: 🇨🇳
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer

Phase 1

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Regorafenib
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2019-07-05

Last Posted Date: 2019-07-05

Lead Sponsor: China Medical University, China

Target Recruit Count: 54

Registration Number: NCT04008511

Locations: 🇨🇳
The First Hospital of China Medical University, Shenyang, Liaoning, China

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Phase 1

Completed

Conditions: Advanced Cancer

Interventions: Drug: BMS-986288
Drug: Nivolumab
Drug: Regorafenib

First Posted Date: 2019-06-21

Last Posted Date: 2024-10-07

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 219

Registration Number: NCT03994601

Locations: 🇺🇸
Local Institution - 0075, Costa Mesa, California, United States
🇺🇸
Local Institution - 0050, Orange, California, United States
🇪🇸
Local Institution - 0024, Majadahonda, Spain

and more 37 locations

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Colorectal Carcinoma
Stage III Rectal Cancer AJCC v8
Stage IIIB Colon Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Colon Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8

Interventions: Biological: Panitumumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Regorafenib
Drug: Trifluridine and Tipiracil Hydrochloride

First Posted Date: 2019-06-20

Last Posted Date: 2024-05-21

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 12

Registration Number: NCT03992456

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

and more 15 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy