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 Second Line Treatment of Metastatic or Advanced Upper GI Cancers

Phase 2

Terminated

Conditions: Upper GI Cancer

Interventions: Drug: regorafenib

First Posted Date: 2014-09-16

Last Posted Date: 2018-01-11

Lead Sponsor: University of Utah

Target Recruit Count: 5

Registration Number: NCT02241720

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery

Phase 2

Terminated

Conditions: Stage IIIC Esophageal Adenocarcinoma
Stage IIB Esophageal Adenocarcinoma
Adenocarcinoma of the Gastroesophageal Junction
Stage IIIB Esophageal Adenocarcinoma
Stage IIIA Esophageal Adenocarcinoma

Interventions: Drug: Regorafenib
Other: Placebo

First Posted Date: 2014-09-09

Last Posted Date: 2018-10-17

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 3

Registration Number: NCT02234180

Locations: 🇺🇸
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

and more 7 locations

Regorafenib + Panitumumab for Colorectal Cancers

Phase 1

Terminated

Conditions: KRAS and NRAS Wild-type Colorectal Cancer

Interventions: Drug: regorafenib + panitumumab

First Posted Date: 2014-07-24

Last Posted Date: 2016-09-22

Lead Sponsor: University of Utah

Target Recruit Count: 2

Registration Number: NCT02199223

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases

Phase 2

Completed

Conditions: Colorectal Neoplasms

Interventions: Device: SIR-Spheres
Drug: Regorafenib

First Posted Date: 2014-07-21

Last Posted Date: 2023-12-05

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 26

Registration Number: NCT02195011

Locations: 🇺🇸
Tennessee Oncology PLLC, Nashville, Tennessee, United States
🇺🇸
Florida Cancer Specialists - North, Saint Petersburg, Florida, United States
🇺🇸
Research Medical Center, Kansas City, Missouri, United States