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
- Associated Therapies
- -
Regorafenib and Nivolumab Simultaneous Combination Therapy
- Conditions
- Interventions
- First Posted Date
- 2018-01-23
- Last Posted Date
- 2021-04-26
- Lead Sponsor
- Kohei Shitara
- Target Recruit Count
- 50
- Registration Number
- NCT03406871
- Locations
- 🇯🇵
NationalCCHE, Kashiwa, Chiba, Japan
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
- Conditions
- Interventions
- First Posted Date
- 2017-12-19
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 325
- Registration Number
- NCT03377361
- Locations
- 🇺🇸
Local Institution - 0111, Miami, Florida, United States
🇨🇱Local Institution - 0118, Santiago, Región Metropolitana De Santiago, Chile
🇺🇸Local Institution - 0002, Madison, Wisconsin, United States
Regorafenib in Combination With TAS-102 in Subjects With Metastatic Colorectal Cancer Who Have Progressed After Standard Therapy
- Conditions
- Interventions
- First Posted Date
- 2017-10-10
- Last Posted Date
- 2021-03-26
- Lead Sponsor
- AIO-Studien-gGmbH
- Target Recruit Count
- 12
- Registration Number
- NCT03305913
- Locations
- 🇩🇪
Universitätsmedizin Mainz, I.Medizinische Klinik und Poliklinik, Mainz, Germany
To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-07-12
- Last Posted Date
- 2023-11-09
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 20
- Registration Number
- NCT03215264
- Locations
- 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC
- Conditions
- Interventions
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2022-02-07
- Lead Sponsor
- Fox Chase Cancer Center
- Target Recruit Count
- 2
- Registration Number
- NCT03099486
- Locations
- 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-03-16
- Last Posted Date
- 2020-12-11
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 10
- Registration Number
- NCT03081494
- Locations
- 🇪🇸
Novartis Investigative Site, Madrid, Spain
Study of Regorafenib in Patients With Advanced Myeloid Malignancies
- First Posted Date
- 2017-02-03
- Last Posted Date
- 2024-03-08
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 16
- Registration Number
- NCT03042689
- Locations
- 🇺🇸
Massachusetts general Hospital, Boston, Massachusetts, United States
Prospective Translational Study Investigating Molecular Predictors of Resistance and Response to Regorafenib Monotherapy
- First Posted Date
- 2017-01-05
- Last Posted Date
- 2021-05-03
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Target Recruit Count
- 49
- Registration Number
- NCT03010722
- Locations
- 🇬🇧
The Royal Marsden NHS Foundation Trust London and Surrey, Carshalton, Surrey, United Kingdom
An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
- Conditions
- Interventions
- First Posted Date
- 2016-11-04
- Last Posted Date
- 2024-11-06
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 10
- Registration Number
- NCT02955940
- Locations
- 🇺🇸
UCLA Healthcare Hematology-Oncology, Santa Monica, California, United States
🇺🇸New York Oncology Hematology Pc., Clifton Park, New York, United States
🇺🇸Tennessee Oncology, Nashville, Tennessee, United States
Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab
- Conditions
- Interventions
- First Posted Date
- 2016-10-17
- Last Posted Date
- 2023-11-15
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Target Recruit Count
- 673
- Registration Number
- NCT02934529
- Locations
- 🇩🇪
Klinikum der Universitaet Muenchen - Campus Grosshadern, Munich, Germany
Drug Development Updates
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