Regorafenib

Generic Name: Regorafenib

Brand Names: Stivarga

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₅ClF_₄N_₄O_₃

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, unresecta...

Associated Conditions: Hepatocellular Carcinoma, Metastatic Colorectal Cancer (CRC), Metastatic Gastrointestinal Stromal Tumor (GIST), Locally advanced Gastrointestinal stromal tumor, Unresectable Gastrointestinal stromal tumor

Associated Therapies: -

Clinical Trials

Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

Phase 1

Not yet recruiting

Conditions: Unresectable Locally Advanced or Metastatic Solid Tumors

Interventions: Drug: SYHA1813
Drug: Everolimus
Drug: SG001
Drug: Regorafenib
Drug: HB1801
Drug: Carboplatin
Drug: Cisplatin
Drug: Paclitaxel
Drug: Etoposide

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

Phase 2

Withdrawn

Conditions: Stage IV Colorectal Cancer AJCC v8
Advanced Colon Adenocarcinoma
Stage IV Colon Cancer AJCC v8
Advanced Colorectal Adenocarcinoma
Metastatic Colorectal Adenocarcinoma
Advanced Rectal Adenocarcinoma
Metastatic Colon Adenocarcinoma
Stage III Colon Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8
Metastatic Rectal Adenocarcinoma

Interventions: Biological: Balstilimab
Procedure: Biopsy
Procedure: Biospecimen Collection
Biological: Botensilimab
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Regorafenib

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 in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Not yet recruiting

Conditions: Myelodysplastic Syndrome/Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Drug: Regorafenib
Drug: Venetoclax

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

Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM

Phase 2

Recruiting

Conditions: CRC

Interventions: Drug: Candonilimab (AK104)
Drug: Regorafenib

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 Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers

Phase 2

Not yet recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Procedure: Blood sample
Other: Quality of life questionnaires
Procedure: Biopsy
Combination Product: Regorafenib + metronomic chemotherapy
Drug: Regorafenib

First Posted Date: 2024-05-22

Last Posted Date: 2024-05-24

Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Target Recruit Count: 174

Registration Number: NCT06425133

Locations: 🇫🇷
ICANS, Strasbourg, France
🇫🇷
CHU d'Auxerre, Auxerre, France
🇫🇷
CH de Colmar, Colmar, France

and more 7 locations

A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

Phase 1

Not yet recruiting

Conditions: Colorectal Cancer Metastatic

Interventions: Biological: T3011 hepatic artery infusion
Drug: toripalimab
Drug: regorafenib

First Posted Date: 2024-02-28

Last Posted Date: 2024-02-29

Lead Sponsor: China Medical University, China

Target Recruit Count: 8

Registration Number: NCT06283303

A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

Phase 1

Not yet recruiting

Conditions: Colorectal Cancer Metastatic

Interventions: Biological: BioTTT001 hepatic artery infusion
Drug: toripalimab
Drug: regorafenib

First Posted Date: 2024-02-28

Last Posted Date: 2024-02-29

Lead Sponsor: China Medical University, China

Target Recruit Count: 40

Registration Number: NCT06283134

A Clinical Study of T3011 in Combination With Regorafenib in Patients With Advanced Colorectal Cancer

Phase 1

Recruiting

Conditions: Advanced Colorectal Cancer

Interventions: Drug: T3011
Drug: Regorafenib

First Posted Date: 2024-01-11

Last Posted Date: 2024-01-11

Lead Sponsor: West China Hospital

Target Recruit Count: 15

Registration Number: NCT06200363

Locations: 🇨🇳
West China Hospital, Sichuan University, Chengdu, Sichuan, China

KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Phase 2

Recruiting

Conditions: Digestive System Cancers

Interventions: Drug: KN046
Drug: Regorafenib
Drug: Apatinib

First Posted Date: 2023-10-25

Last Posted Date: 2023-10-26

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 39

Registration Number: NCT06099821

Locations: 🇨🇳
Peking University Cancer Hospital, Beijing, China

Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients

Phase 1

Recruiting

Conditions: Glioblastoma, IDH-wildtype
MGMT-Methylated Glioblastoma

Interventions: Drug: Regorafenib
Drug: Temozolomide

First Posted Date: 2023-10-23

Last Posted Date: 2024-02-12

Lead Sponsor: Istituto Oncologico Veneto IRCCS

Target Recruit Count: 36

Registration Number: NCT06095375

Locations: 🇮🇹
Istituto Oncologico Veneto IRCCS, Padova, Italy

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