Regorafenib
- Generic Name
- Regorafenib
- Brand Names
- Stivarga
- Drug Type
- Small Molecule
- Chemical Formula
- C21H15ClF4N4O3
- 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
Single Agent Regorafenib in Refractory Advanced Biliary Cancers
- First Posted Date
- 2014-04-16
- Last Posted Date
- 2021-10-12
- Target Recruit Count
- 39
- Registration Number
- NCT02115542
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇺🇸UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸VCU Massey Cancer Center, Richmond, Virginia, United States
Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.
- Conditions
- Neoplasms
- Interventions
- First Posted Date
- 2014-04-08
- Last Posted Date
- 2019-06-07
- Lead Sponsor
- Bayer
- Target Recruit Count
- 42
- Registration Number
- NCT02106845
Stivarga Regulatory Post-Marketing Surveillance Study in Korea
- First Posted Date
- 2014-04-08
- Last Posted Date
- 2023-07-24
- Lead Sponsor
- Bayer
- Target Recruit Count
- 316
- Registration Number
- NCT02106858
Regorafenib in Patients with Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
- First Posted Date
- 2014-03-28
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 38
- Registration Number
- NCT02098538
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, 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
A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
- Conditions
- Colorectal Neoplasms
- Interventions
- First Posted Date
- 2014-03-26
- Last Posted Date
- 2024-10-11
- Lead Sponsor
- EpicentRx, Inc.
- Target Recruit Count
- 62
- Registration Number
- NCT02096354
- Locations
- 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸Kaiser Permanete, Honolulu, Hawaii, United States
🇺🇸Stanford University, Stanford, California, United States
Regorafenib and Cetuximab in Patients With Advanced Malignancy
- Conditions
- Advanced Cancers
- Interventions
- First Posted Date
- 2014-03-24
- Last Posted Date
- 2021-04-01
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 39
- Registration Number
- NCT02095054
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy
- Conditions
- Pediatric Oncology
- Interventions
- First Posted Date
- 2014-03-12
- Last Posted Date
- 2024-04-22
- Lead Sponsor
- Bayer
- Target Recruit Count
- 62
- Registration Number
- NCT02085148
A Study of Regorafenib in Advanced Pancreatic Cancer Patients
- First Posted Date
- 2014-03-06
- Last Posted Date
- 2022-04-21
- Lead Sponsor
- Wake Forest University Health Sciences
- Target Recruit Count
- 20
- Registration Number
- NCT02080260
- Locations
- 🇺🇸
Low Country Hematology Oncology, Charleston, South Carolina, United States
🇺🇸Levine Cancer Institute-Albemarle, Albemarle, North Carolina, United States
🇺🇸Levine Cancer Institute-South Tryon, Charlotte, North Carolina, United States
A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy
- First Posted Date
- 2014-02-03
- Last Posted Date
- 2019-01-30
- Lead Sponsor
- Nathan Bahary, MD
- Target Recruit Count
- 43
- Registration Number
- NCT02053376
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
- Conditions
- LiposarcomaEwing/Ewing-like SarcomaRhabdomyosarcomaMesenchymal ChondrosarcomaOsteogenic Sarcoma
- Interventions
- Drug: Placebo
- First Posted Date
- 2014-01-29
- Last Posted Date
- 2023-11-07
- Target Recruit Count
- 131
- Registration Number
- NCT02048371
- Locations
- 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸Sarcoma Oncology Research Center, Santa Monica, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
Drug Development Updates
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