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, 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: -

Clinical Trials

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

Phase 2

Recruiting

Conditions: Lymphoma, Non-Hodgkin
Multiple Myeloma
Advanced Solid Tumors

Interventions: Drug: Sunitinib
Drug: Vemurafenib and Cobimetinib
Drug: Palbociclib
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Atezolizumab and PHESGO
Drug: Atezolizumab and Talazoparib
Drug: Futibatinib
Drug: Trastuzumab and Pertuzumab
Drug: Tucatinib plus Trastuzumab Subcutaneous (SC)
Drug: Talazoparib
Drug: Temsirolimus
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Entrectinib
Drug: Larotrectinib

First Posted Date: 2016-02-26

Last Posted Date: 2024-12-27

Lead Sponsor: American Society of Clinical Oncology

Target Recruit Count: 3791

Registration Number: NCT02693535

Locations: 🇺🇸
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
Cancer Treatment Centers of America-Phoenix, Phoenix, Arizona, United States
🇺🇸
Sutter Auburn, Auburn, California, United States

and more 125 locations

A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer

Phase 3

Terminated

Conditions: Stage III (IIIB or IIIC) Colon Cancer

Interventions: Drug: Placebo
Drug: Regorafenib

First Posted Date: 2016-01-26

Last Posted Date: 2022-04-14

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 34

Registration Number: NCT02664077

Locations: 🇺🇸
McLeod Cancer Center for Treatment and Research, Florence, South Carolina, United States
🇺🇸
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
🇺🇸
First Health of the Carolinas Cancer Center, Pinehurst, North Carolina, United States

and more 48 locations

A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: Thyroid Cancer

Interventions: Drug: Regorafenib

First Posted Date: 2016-01-18

Last Posted Date: 2024-11-11

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 8

Registration Number: NCT02657551

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States

Phase II Study of Perindopril and Regorafenib in mCRC

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Regorafenib
Drug: Perindopril

First Posted Date: 2016-01-11

Last Posted Date: 2019-09-12

Lead Sponsor: British Columbia Cancer Agency

Target Recruit Count: 12

Registration Number: NCT02651415

Locations: 🇨🇦
BC Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST

Phase 2

Completed

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: regorafenib

First Posted Date: 2015-12-23

Last Posted Date: 2023-03-27

Lead Sponsor: Grupo Espanol de Investigacion en Sarcomas

Target Recruit Count: 15

Registration Number: NCT02638766

Locations: 🇪🇸
Hospital Universitario de Canarias, La Laguna, Santa Cruz De Tenerife, Spain
🇪🇸
Hospital Universitario Virgen del Rocío, Sevilla, Spain
🇮🇹
Policlinico Universitario Campus Bio-Medico, Roma, Italy

and more 14 locations

Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Advanced Colorectal Cancer

Interventions: Drug: regorafenib

First Posted Date: 2015-12-02

Last Posted Date: 2023-03-24

Lead Sponsor: National Cancer Institute, Naples

Target Recruit Count: 46

Registration Number: NCT02619435

Locations: 🇮🇹
AO G. Rummo, Benevento, Italy
🇮🇹
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy
🇮🇹
Seconda Università di Napoli, Napoli, Italy

and more 1 locations

Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

Phase 2

Completed

Conditions: Gastrointestinal Stromal Tumour (GIST)

Interventions: Drug: regorafenib

First Posted Date: 2015-11-17

Last Posted Date: 2019-03-21

Lead Sponsor: Chang Gung Memorial Hospital

Target Recruit Count: 19

Registration Number: NCT02606097

Locations: 🇨🇳
Chang Gung Memorial Hospital, Taoyuan, Taiwan

Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma

Phase 2

Terminated

Conditions: ALK Fusion Protein Expression
NRAS wt Allele
NTRK1 Fusion Positive
NTRK2 Fusion Positive
NTRK3 Fusion Positive
RET Fusion Positive
ROS1 Fusion Positive
Stage IV Cutaneous Melanoma
Stage IIIA Cutaneous Melanoma
Stage IIIB Cutaneous Melanoma

Interventions: Drug: Capmatinib
Drug: Ceritinib
Drug: Entrectinib
Other: Laboratory Biomarker Analysis
Drug: Regorafenib

First Posted Date: 2015-10-27

Last Posted Date: 2020-01-27

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 1

Registration Number: NCT02587650

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

REGorafenib vsTamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

Phase 2

Completed

Conditions: Ovarian Carcinoma

Interventions: Drug: Tamoxifen
Drug: Regorafenib

First Posted Date: 2015-10-22

Last Posted Date: 2023-09-06

Lead Sponsor: ARCAGY/ GINECO GROUP

Target Recruit Count: 68

Registration Number: NCT02584465

Locations: 🇫🇷
ORACLE - Centre d'Oncologie de Gentilly, Nancy, France
🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
Centre Catherine de Sienne, Nantes, France

and more 18 locations

Efficacy of Ginseng for Patients on Regorafenib

Phase 2

Terminated

Conditions: Colorectal Cancer
Palliative Medicine
Supportive Care

Interventions: Drug: Regorafenib
Dietary Supplement: Ginseng

First Posted Date: 2015-10-20

Last Posted Date: 2024-06-26

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 10

Registration Number: NCT02581059

Locations: 🇺🇸
Indiana Univeristy Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
IU Health Central Indiana Cancer Centers, Indianapolis, Indiana, United States
🇺🇸
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States

and more 2 locations

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