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
Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes
- Conditions
- Metastatic Colorectal Cancer (mCRC)Colorectal Neoplasms
- Interventions
- Combination Product: experimental group x-MAP
- First Posted Date
- 2025-04-29
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Sergey Orlov, MD
- Target Recruit Count
- 60
- Registration Number
- NCT06949982
- Locations
- 🇷🇺
First Pavlov State Medical University, St. Petersburg, Russian Federation
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
- Conditions
- Unresectable Hepatocellular CarcinomaHepatocellular Carcinoma
- Interventions
- Radiation: TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
- First Posted Date
- 2025-03-30
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- University of Miami
- Target Recruit Count
- 28
- Registration Number
- NCT06902246
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Interventions
- First Posted Date
- 2025-03-25
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- The Methodist Hospital Research Institute
- Target Recruit Count
- 56
- Registration Number
- NCT06887218
- Locations
- 🇺🇸
Houston Methodist Neal Cancer Center, Houston, Texas, United States
"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
- Conditions
- MCRC
- Interventions
- First Posted Date
- 2025-02-17
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- Beijing Friendship Hospital
- Target Recruit Count
- 52
- Registration Number
- NCT06829355
- Locations
- 🇨🇳
Beijing Friendship Hospital, Capital Medical University, Beijing, China
Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body
- Conditions
- CIC-Rearranged SarcomaSarcoma With BCOR Genetic AlterationsMetastatic Ewing SarcomaMetastatic High Grade SarcomaMetastatic Undifferentiated Round Cell SarcomaRound Cell Sarcoma With EWSR1-non-ETS FusionMetastatic Undifferentiated Sarcoma, Not Otherwise Specified
- Interventions
- Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Echocardiography TestOther: Fludeoxyglucose F-18Procedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Questionnaire AdministrationRadiation: Radiation TherapyProcedure: Surgical Procedure
- First Posted Date
- 2025-02-11
- Last Posted Date
- 2025-04-10
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 437
- Registration Number
- NCT06820957
Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.
- Conditions
- Unresectable Locally Advanced or Metastatic Solid Tumors
- Interventions
- First Posted Date
- 2024-11-11
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Target Recruit Count
- 380
- Registration Number
- NCT06682611
Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer
- Conditions
- Stage IV Colorectal Cancer AJCC v8Advanced Colon AdenocarcinomaStage IV Colon Cancer AJCC v8Advanced Colorectal AdenocarcinomaMetastatic Colorectal AdenocarcinomaAdvanced Rectal AdenocarcinomaMetastatic Colon AdenocarcinomaStage III Colon Cancer AJCC v8Stage IV Rectal Cancer AJCC v8Metastatic Rectal Adenocarcinoma
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance Imaging
- First Posted Date
- 2024-08-28
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 84
- Registration Number
- NCT06575725
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- First Posted Date
- 2024-06-13
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- The First People's Hospital of Changzhou
- Target Recruit Count
- 30
- Registration Number
- NCT06456515
- Locations
- 🇨🇳
The First People's Hospital of Changzhou, Changzhou, China
Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM
- First Posted Date
- 2024-06-12
- Last Posted Date
- 2024-07-30
- Lead Sponsor
- Jin-hong Chen
- Target Recruit Count
- 44
- Registration Number
- NCT06455254
- Locations
- 🇨🇳
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
🇨🇳Shanghai Tenth People's Hospital, Shanghai, China
🇨🇳Huashan Hospital, Shanghai, China
Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Conditions
- Myelodysplastic Syndrome/Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Myelodysplastic Syndrome
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration
- First Posted Date
- 2024-06-12
- Last Posted Date
- 2024-06-12
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 20
- Registration Number
- NCT06454409
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Drug Development Updates
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