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

Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

Phase 2

Not yet recruiting

Conditions: Intrahepatic Cholangiocarcinoma

Interventions: Drug: Regorafenib and HAIC
Drug: FOLFOX

First Posted Date: 2022-09-10

Last Posted Date: 2022-09-10

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 60

Registration Number: NCT05535647

Locations: 🇨🇳
Tianjin Medical University Cancer Institute and Hospital, Tianjin, China

Sintilimab Combined With Regorafenib and HAIC in Patients With Colorectal Liver Metastasis

Phase 2

Not yet recruiting

Conditions: Liver Metastasis
Colorectal Cancer

Interventions: Drug: HAIC
Drug: Sintilimab
Drug: Regorafenib

First Posted Date: 2022-09-01

Last Posted Date: 2022-09-01

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 30

Registration Number: NCT05524155

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

Phase 2

Conditions: Colorectal Cancer Liver Metastases

Interventions: Other: Radiofrequency ablation
Drug: Regorafenib and Toripalimab Combination

First Posted Date: 2022-08-03

Last Posted Date: 2022-08-03

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 32

Registration Number: NCT05485909

Locations: 🇨🇳
Zhiqiang Wang, Guangzhou, Other (Non U.s.), China

Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer

Phase 2

Recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Other: quality of life questionnaires
Procedure: Blood sample
Drug: Regorafenib
Drug: Metronomic chemotherapies
Drug: Aspirin
Drug: Bevacizumab
Drug: FOLFIRI or FOLFOX

First Posted Date: 2022-07-18

Last Posted Date: 2024-12-20

Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Target Recruit Count: 446

Registration Number: NCT05462613

Locations: 🇫🇷
Hôpital Privé Jean Mermoz, Lyon, France
🇫🇷
CHU Estain, Clermont-Ferrand, France
🇫🇷
CHU Montpellier, Montpellier, France

and more 13 locations

Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients

Phase 1

Not yet recruiting

Conditions: Regorafenib
Raltitrexed
Colorectal Neoplasms
Third-line Treatment

Interventions: Drug: Regorafenib
Drug: Raltitrexed

First Posted Date: 2022-06-22

Last Posted Date: 2022-06-29

Lead Sponsor: China Medical University, China

Target Recruit Count: 50

Registration Number: NCT05426811

Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Phase 3

Active, not recruiting

Conditions: Colorectal Cancer

Interventions: Drug: XL092
Drug: Regorafenib
Drug: Atezolizumab

First Posted Date: 2022-06-21

Last Posted Date: 2024-07-05

Lead Sponsor: Exelixis

Target Recruit Count: 874

Registration Number: NCT05425940

Locations: 🇺🇸
Exelixis Clinical Site #77, Los Angeles, California, United States
🇺🇸
Exelixis Clinical Site #106, Philadelphia, Pennsylvania, United States
🇺🇸
Exelixis Clinical Site #103, Pittsburgh, Pennsylvania, United States

and more 130 locations