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
Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy (Managed Access Program)
- Conditions
- Gastrointestinal Stromal Tumors
- First Posted Date
- 2012-09-21
- Last Posted Date
- 2016-08-16
- Lead Sponsor
- Bayer
- Registration Number
- NCT01689376
Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy
- Conditions
- Gastrointestinal Stromal Tumors
- First Posted Date
- 2012-07-20
- Last Posted Date
- 2014-12-15
- Lead Sponsor
- Bayer
- Registration Number
- NCT01646593
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
- Conditions
- Colorectal Neoplasms
- Interventions
- Drug: Placebo
- First Posted Date
- 2012-04-25
- Last Posted Date
- 2016-02-08
- Lead Sponsor
- Bayer
- Target Recruit Count
- 204
- Registration Number
- NCT01584830
Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
- Conditions
- Colorectal Neoplasms
- First Posted Date
- 2012-02-24
- Last Posted Date
- 2019-05-29
- Lead Sponsor
- Bayer
- Registration Number
- NCT01538680
Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity
- First Posted Date
- 2011-04-20
- Last Posted Date
- 2014-10-01
- Lead Sponsor
- Bayer
- Target Recruit Count
- 53
- Registration Number
- NCT01339104
Effect of Rifampin on the Pharmacokinetics of BAY73-4506
- First Posted Date
- 2011-03-24
- Last Posted Date
- 2014-12-19
- Lead Sponsor
- Bayer
- Target Recruit Count
- 24
- Registration Number
- NCT01322438
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
- Conditions
- Pharmacokinetics
- Interventions
- First Posted Date
- 2011-03-18
- Last Posted Date
- 2014-11-02
- Lead Sponsor
- Bayer
- Target Recruit Count
- 24
- Registration Number
- NCT01318265
Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- First Posted Date
- 2011-02-17
- Last Posted Date
- 2021-01-06
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 181
- Registration Number
- NCT01298570
- Locations
- 🇺🇸
Portsmouth Naval Medical Center, Portsmouth, Virginia, United States
🇺🇸Rocky Mountain Cancer Centers, Denver, Colorado, United States
🇺🇸University of Virginia, Charlottesville, Virginia, United States
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
- Conditions
- Colorectal Neoplasms
- Interventions
- First Posted Date
- 2011-02-04
- Last Posted Date
- 2017-03-15
- Lead Sponsor
- Bayer
- Target Recruit Count
- 54
- Registration Number
- NCT01289821
BAY73-4506 Probe Substrate Study
- Conditions
- Neoplasms
- Interventions
- First Posted Date
- 2011-02-01
- Last Posted Date
- 2019-07-10
- Lead Sponsor
- Bayer
- Target Recruit Count
- 41
- Registration Number
- NCT01287598
- Locations
- 🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada
🇨🇦British Columbia Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada
Drug Development Updates
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