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 Post-marketing Surveillance in Japan

Completed

Conditions: Gastrointestinal Stromal Tumors

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

First Posted Date: 2013-09-02

Last Posted Date: 2022-04-01

Lead Sponsor: Bayer

Target Recruit Count: 72

Registration Number: NCT01933958

Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)

Phase 2

Completed

Conditions: Advanced Chemorefractory Colorectal Adenocarcinoma

Interventions: Drug: regorafenib

First Posted Date: 2013-08-28

Last Posted Date: 2019-06-25

Lead Sponsor: Jules Bordet Institute

Target Recruit Count: 141

Registration Number: NCT01929616

Locations: 🇧🇪
Hopital Erasme, Brussels, Belgium
🇧🇪
Jules Bordet Institute, Brussels, Belgium
🇧🇪
Centre hospitalier de Jolimont, Lobbes, Belgium

and more 14 locations

FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer

Phase 2

Completed

Conditions: Esophageal Cancer
Gastric Cancer

Interventions: Drug: Regorafenib
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin

First Posted Date: 2013-08-01

Last Posted Date: 2020-05-15

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 39

Registration Number: NCT01913639

Locations: 🇺🇸
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States

and more 2 locations

Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma

Phase 2

Completed

Conditions: Sarcoma

Interventions: Drug: Placebo
Drug: Regorafenib

First Posted Date: 2013-07-16

Last Posted Date: 2021-04-09

Lead Sponsor: Centre Oscar Lambret

Target Recruit Count: 219

Registration Number: NCT01900743

Locations: 🇦🇹
Medizinische Universität Graz, Graz, Austria
🇦🇹
LKH, Klagenfurt, Austria
🇫🇷
Hôpital St Jacques, Besancon, France

and more 22 locations

Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Previously Treated Metastatic Colorectal Cancer

Interventions: Drug: SGI-110
Drug: SGI-110 Dose Escalation
Drug: Regorafenib
Drug: Irinotecan
Drug: TAS-102

First Posted Date: 2013-07-11

Last Posted Date: 2020-10-06

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 118

Registration Number: NCT01896856

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 1 locations