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
Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- Conditions
- Recurrent Adult Soft Tissue SarcomaStage IV Adult Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaAdult Angiosarcoma
- Interventions
- First Posted Date
- 2014-01-29
- Last Posted Date
- 2022-04-25
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 31
- Registration Number
- NCT02048722
- Locations
- 🇺🇸
Sarcoma Oncology Center, Santa Monica, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸Washington University-St. Louis, Saint Louis, Missouri, United States
Safety and Effectiveness of Regorafenib
- First Posted Date
- 2014-01-22
- Last Posted Date
- 2018-01-16
- Lead Sponsor
- Bayer
- Target Recruit Count
- 1034
- Registration Number
- NCT02042144
A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer
- Conditions
- Advanced Gastrointestinal Cancer
- Interventions
- First Posted Date
- 2013-12-31
- Last Posted Date
- 2023-11-15
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 495
- Registration Number
- NCT02024607
- Locations
- 🇺🇸
Parkview Research Center, Fort Wayne, Indiana, United States
🇺🇸Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States
Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Interventions
- First Posted Date
- 2013-12-30
- Last Posted Date
- 2025-01-22
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 11
- Registration Number
- NCT02023333
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center at Mercy Medical Center, Rockville Centre, New York, United States
🇺🇸Queens Cancer Center of Queens Hospital, Jamaica, New York, United States
Effect of Neomycin on the Pharmacokinetics of Regorafenib
- Conditions
- Neoplasms
- Interventions
- First Posted Date
- 2013-12-05
- Last Posted Date
- 2015-08-13
- Lead Sponsor
- Bayer
- Target Recruit Count
- 27
- Registration Number
- NCT02001909
Identification of Predictive Biomarker of Regorafenib in Refractory Colorectal Cancer
- First Posted Date
- 2013-11-27
- Last Posted Date
- 2019-02-22
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 117
- Registration Number
- NCT01996969
- Locations
- 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
- Conditions
- Neoplasms
- Interventions
- First Posted Date
- 2013-11-01
- Last Posted Date
- 2019-04-09
- Lead Sponsor
- Bayer
- Target Recruit Count
- 42
- Registration Number
- NCT01973868
- Locations
- 🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸University of Southern California, Los Angeles, California, United States
🇺🇸University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, United States
Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy
- First Posted Date
- 2013-10-09
- Last Posted Date
- 2018-03-08
- Lead Sponsor
- Bayer
- Target Recruit Count
- 483
- Registration Number
- NCT01959269
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
- First Posted Date
- 2013-09-24
- Last Posted Date
- 2018-08-10
- Lead Sponsor
- Gerald Batist
- Target Recruit Count
- 48
- Registration Number
- NCT01949194
- Locations
- 🇨🇦
McGill University Health Centre, Montréal, Quebec, Canada
🇨🇦Hopital Maisonneuve-Rosemont, Montreal, Canada
🇨🇦St-Mary's Hospital Centre, Montreal, Quebec, Canada
Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy
- Conditions
- Colorectal Neoplasms
- Interventions
- Drug: Placebo
- First Posted Date
- 2013-09-11
- Last Posted Date
- 2017-10-20
- Lead Sponsor
- Bayer
- Target Recruit Count
- 25
- Registration Number
- NCT01939223
- Locations
- 🇬🇧
Royal Marsden NHS Trust (Surrey), Sutton, Surrey, United Kingdom
🇨🇳Fujian Medical University Union Hospital, Fuzhou, Fujian, China
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.