Stivarga

(Regorafenib)

ApprovedSmall molecule

Regorafenib is used to treat certain advanced cancers, including colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma. It works by blocking proteins that help cancer cells grow and spread.[2] Stivarga is currently approved and in use across 44 indications[4].[1]

Stivarga is one of 751 small molecule programs targeting Gastric Cancer. It is currently in Approved.

Indications

270

Total Trials

Active Trials

750

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Gastric CancerCompleted

Colorectal CancerUnknown status

Rectum CancerApproved

Renal Cell CarcinomaApproved

Ovarian NeoplasmApproved

Colon AdenocarcinomaApproved

TreatmentRecruiting

Neoplasm of the LiverActive, not recruiting

Liver NeoplasmActive, not recruiting

Colorectal NeoplasmActive, not recruiting

Gastric CancerPhase 2

Completed

Colorectal CancerPhase 3

Unknown status

Rectum CancerApproved

Approved

Renal Cell CarcinomaApproved

Approved

Ovarian NeoplasmApproved

Approved

Colon AdenocarcinomaApproved

Approved

TreatmentPhase 2

Recruiting

Neoplasm of the LiverPreclinical

Active, not recruiting

Liver NeoplasmPreclinical

Active, not recruiting

Colorectal NeoplasmApproved

Active, not recruiting

Showing 10 of 44 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Stivarga

Bayer

Approved

6 2

Biltricide

Bayer

Preclinical

4 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Emtriva

Gilead

Preclinical

1 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Valium

Akero Therapeutics

Preclinical

2 8

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 9

Reminyl

WWim Janssens

Preclinical

1 10

Clomid

Ferring

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Colorectal Cancer

NCT05057052

Q4 2026

Phase 2Recruiting

Cancer

NCT05159245

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT05985109

Phase 2Recruiting

Digestive System Cancer

NCT06099821

Q1 2027

Phase 2Active, not recruiting

Gastric Cancer

NCT04757363

Phase 2Recruiting

Meningioma

NCT06275919

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer48 trials

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT03081494·10 enrolled

Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer

Completed·—·Phase 1·NCT04362839·39 enrolled

Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

Completed·TTaipei Veterans General Hospital, Taiwan··NCT03829852·716 enrolled

Show 45 more trials

Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Completed·KKaohsiung Medical University Chung-Ho Memorial Hospital·N/A·NCT03698253·41 enrolled

Regorafenib in Combination With TAS-102 in Subjects With Metastatic Colorectal Cancer Who Have Progressed After Standard Therapy

Completed·AAIO-Studien-gGmbH·Phase 1·NCT03305913·12 enrolled

A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

Terminated·GGeorgetown University·Phase 2·NCT02402036·10 enrolled

KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer

Recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT05985109·98 enrolled

Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer

Completed·HHunan Cancer Hospital··NCT05942768·103 enrolled

Regorafenib and PD-1 Antibody in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer

Unknown status·SSun Yat-sen University·Phase 2·NCT04030260·28 enrolled

Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer

Withdrawn·CCytoDyn, Inc.·Phase 2·NCT05730673

Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer

Terminated·UUNICANCER·Phase 2·NCT04450836·234 enrolled

Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers

Recruiting·—·Phase 2·NCT06425133·174 enrolled

Regorafenib in Frail and/or Unfit for Chemotherapy Patients With Metastatic Colorectal Cancer

Completed·SSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)·Phase 2·NCT01875380·46 enrolled

Regorafenib in Metastatic Colorectal Cancer

Completed·UUniversity of Rochester·Phase 2·NCT02466009·27 enrolled

Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers

Unknown status·GGerald Batist·Phase 2·NCT01949194·48 enrolled

A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Completed·EEpicentRx, Inc.·Phase 2·NCT02096354·62 enrolled

Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

Active, not recruiting·UUniversity of Southern California·Phase 1/2·NCT03657641·75 enrolled

Evaluation of Treatment PERSOnalization Based on Its Therapeutic Monitoring in Patients With Metastatic Colorectal Cancer Treated With REgorafenib

Completed·RRennes University Hospital·Phase 4·NCT04874207·110 enrolled

Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer

Completed·—·Phase 2·NCT04534218·49 enrolled

Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT02195011·26 enrolled

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

Terminated· Roche logo

Roche·Phase 1/2·NCT03555149·96 enrolled

The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer

Not yet recruiting·SShanghai JMT-Bio Inc.·Phase 3·NCT07134205·252 enrolled

Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)

Unknown status·WWei Zhang·N/A·NCT05818267·30 enrolled

Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT01896856·118 enrolled

Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab

Completed·LLudwig-Maximilians - University of Munich·Phase 3·NCT02934529·673 enrolled

Evaluation of Treatment Response With CHOI and RECIST Criteria and CT Texture Analysis in Patients With Metastatic Colorectal Cancer Treated With Regorafenib

Completed·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT02699073·55 enrolled

A Study of JMT101 in Patients With Metastatic Colorectal Cancer

Unknown status·SShanghai JMT-Bio Inc.·Phase 2·NCT06089330·102 enrolled

Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer

Completed· Bayer logo

Bayer··NCT02347852·25 enrolled

5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer

Recruiting·TThe Methodist Hospital Research Institute·Phase 2·NCT06887218·57 enrolled

Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT01298570·181 enrolled

Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

Completed· Bayer logo

Bayer··NCT03386825·76 enrolled

Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

No longer available· Bayer logo

Bayer··NCT01538680

Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

Completed· Bayer logo

Bayer·Phase 4·NCT03564938·100 enrolled

First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

Completed· Bayer logo

Bayer·Phase 2·NCT01289821·54 enrolled

Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

Completed· Bayer logo

Bayer·Phase 3·NCT01103323·760 enrolled

A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?

Terminated· Bayer logo

Bayer·Phase 4·NCT02287025·23 enrolled

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

Recruiting·SSergey Orlov, MD·Phase 2·NCT06949982·60 enrolled

A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment

Completed· Bayer logo

Bayer··NCT06137170·121 enrolled

Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy

Completed· Bayer logo

Bayer··NCT01959269·483 enrolled

An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States

Completed· Bayer logo

Bayer··NCT06029010·2,326 enrolled

Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

Completed· Bayer logo

Bayer·Phase 3·NCT01584830·204 enrolled

An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions

Completed· Bayer logo

Bayer··NCT05839951·818 enrolled

Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

Completed· Bayer logo

Bayer·Phase 3·NCT01853319·100 enrolled

Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer

Active, not recruiting·—·Phase 2·NCT04117945·22 enrolled

Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Recruiting·FFudan University·Phase 2·NCT05963490·108 enrolled

Regorafenib as Single Agent in Patients With Metastatic Colorectal Cancer (mCRC) With Any RAS or BRAF Mutation Previously Treated With FOLFOXIRI Plus Bevacizumab

Terminated·SSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)·Phase 2·NCT02175654·15 enrolled

Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting

Completed·CCentre Oscar Lambret··NCT02310477·704 enrolled

To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer

Completed·—·Phase 1·NCT03215264·20 enrolled

Colorectal Cancer30 trials

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

Unknown status·—·Phase 1·NCT06283303·8 enrolled

Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Unknown status·SShanghai Changzheng Hospital·Phase 1/2·NCT04110093·120 enrolled

Regorafenib + Panitumumab for Colorectal Cancers

Terminated·UUniversity of Utah·Phase 1·NCT02199223·2 enrolled

Show 27 more trials

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT05600309·94 enrolled

Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

Unknown status·NNational University Hospital, Singapore·Phase 2/3·NCT01189903

Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases

Recruiting·SSun Yat-sen University·Phase 3·NCT05794971·126 enrolled

TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

Unknown status·—··NCT05993702·45 enrolled

Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer

Unknown status·PPeking Union Medical College Hospital··NCT04771715·100 enrolled

Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03712943·52 enrolled

Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer

Withdrawn·—·Phase 2·NCT06575725

Identification of Predictive Biomarker of Regorafenib in Refractory Colorectal Cancer

Completed·SSeoul National University Hospital·N/A·NCT01996969·117 enrolled

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Active, not recruiting·—·Phase 2·NCT03992456·12 enrolled

Safety Study of Regorafenib With PF-03446962 to Treat Colorectal Cancer

Completed·—·Phase 1·NCT02116894·11 enrolled

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

Unknown status·NNational Cancer Institute, Naples·Phase 2·NCT02619435·46 enrolled

Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT02316340·42 enrolled

QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

Terminated·IImmunityBio, Inc.·Phase 1/2·NCT03563157·2 enrolled

JS001 Combined With Regorafenib in Patients With Advanced Colorectal Cancer

Unknown status·SSun Yat-sen University·Phase 1/2·NCT03946917·44 enrolled

Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer

Completed· Bayer logo

Bayer·Phase 2·NCT02465502·59 enrolled

Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

Completed· Bayer logo

Bayer·Phase 2·NCT04126733·70 enrolled

STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

Recruiting·NNational Cancer Institute, Naples·Phase 2·NCT07213570·60 enrolled

Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial

Unknown status·OOspedale Policlinico San Martino·Phase 2·NCT05382741·182 enrolled

"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"

Recruiting·—·Phase 2·NCT06829355·52 enrolled

Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy

Terminated· Bayer logo

Bayer·Phase 3·NCT01939223·25 enrolled

Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)

Completed·JJules Bordet Institute·Phase 2·NCT01929616·141 enrolled

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

Not yet recruiting·—·Phase 1·NCT06283134·60 enrolled

Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis

Recruiting·FFudan University·Phase 2·NCT05057052·25 enrolled

Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

Terminated·UUS Oncology Research·Phase 2·NCT02425683·24 enrolled

Study of Ruxolitinib in Colorectal Cancer Patients

Terminated· Incyte logo

Incyte·Phase 2·NCT02119676·396 enrolled

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

Unknown status·WWest China Hospital·Phase 1·NCT06200363·15 enrolled

Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT05900648

Hepatocellular Carcinoma19 trials

Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Recruiting·FFudan University·Phase 2·NCT07100392·141 enrolled

Combination of Regorafenib and Nivolumab in Unresectable Hepatocellular Carcinoma

Completed·—·Phase 2·NCT04310709·42 enrolled

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma

Recruiting·UUniversity of Miami·Phase 2·NCT06902246·30 enrolled

Show 16 more trials

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Recruiting·TTongji Hospital··NCT05717738·300 enrolled

Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy

Unknown status·WWenBo Guo··NCT05811481·192 enrolled

Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING)

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 1/2·NCT04170556·69 enrolled

Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

Active, not recruiting·XXi'an Xintong Pharmaceutical Research Co.,Ltd.·Phase 2/3·NCT07300488·60 enrolled

Regorafenib Combined With PD-1 Inhibitor Therapy for Second-line Treatment of Hepatocellular Carcinoma

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05048017·20 enrolled

Chidamide + Regorafenib in Hepatocellular Carcinoma (HCC)

Terminated·GGreat Novel Therapeutics Biotech & Medicals Corporation·Phase 1/2·NCT05770882·7 enrolled

Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy

Unknown status·—·Phase 2·NCT05962450·84 enrolled

Comparing the Combination of Trastuzumab and Regorafenib With Regorafenib Monotherapy for Advanced Hepatocellular Carcinoma After First-line Treatment

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07078305·134 enrolled

A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

Not yet recruiting·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 2/3·NCT07392866·120 enrolled

Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma

Recruiting·ZZhejiang Hisun Pharmaceutical Co. Ltd.·Phase 2·NCT07310173·75 enrolled

A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

Not yet recruiting·FFudan University·Phase 2·NCT07328009·350 enrolled

Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment

Terminated· Bayer logo

Bayer··NCT03644511·3 enrolled

Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

Completed· Bayer logo

Bayer··NCT03289273·1,010 enrolled

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma

Completed· Bayer logo

Bayer·Phase 3·NCT01774344·573 enrolled

Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma

Unknown status·IInstituto do Cancer do Estado de São Paulo·Phase 2·NCT05622136·28 enrolled

A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma

Recruiting·ZZhejiang University·Phase 1·NCT05155189·72 enrolled

Gastrointestinal Stromal Tumor6 trials

A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment

Not yet recruiting·PPeking University·Phase 2·NCT06772233·100 enrolled

A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Not yet recruiting·NNingbo Newbay Technology Development Co., Ltd·Phase 2/3·NCT07379047·255 enrolled

Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy (Managed Access Program)

No longer available· Bayer logo

Bayer··NCT01689376

Show 3 more trials

Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy

No longer available· Bayer logo

Bayer··NCT01646593

An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States

Completed· Bayer logo

Bayer··NCT06321055·136 enrolled

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)

Completed· Bayer logo

Bayer·Phase 3·NCT01271712·199 enrolled

Tics6 trials

Effect of Rifampin on the Pharmacokinetics of BAY73-4506

Completed· Bayer logo

Bayer·Phase 1·NCT01322438·24 enrolled

Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

Completed· Bayer logo

Bayer·Phase 1·NCT01318265·24 enrolled

Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI

Completed· Bayer logo

Bayer·Phase 1·NCT00934882·45 enrolled

Show 3 more trials

Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination

Completed· Bayer logo

Bayer·Phase 1·NCT01973868·42 enrolled

The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib

Completed· Bayer logo

Bayer·Phase 1·NCT01002378·24 enrolled

Effect of Neomycin on the Pharmacokinetics of Regorafenib

Completed· Bayer logo

Bayer·Phase 1·NCT02001909·27 enrolled

68 more indications

Pancreatic Cancer3 trials

A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer

Recruiting·—·Phase 1/2·NCT07040228·23 enrolled

A Study of Regorafenib in Advanced Pancreatic Cancer Patients

Completed·WWake Forest University Health Sciences·Phase 2·NCT02080260·20 enrolled

Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer

Terminated·—·Phase 2·NCT02383433·2 enrolled

Pembrolizumab3 trials

Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7

Terminated·TTranslational Research in Oncology·Phase 3·NCT04777851·45 enrolled

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Recruiting·TTeclison Ltd.·Phase 2·NCT04701476·110 enrolled

Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC

Completed· Bayer logo

Bayer·Phase 1·NCT03347292·58 enrolled

Treatment3 trials

Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2·NCT04806243·69 enrolled

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

Recruiting·JJin-hong Chen·Phase 2·NCT06455254·44 enrolled

HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure

Unknown status·TThe Central Hospital of Lishui City·N/A·NCT05233358·176 enrolled

Trial2 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Chemotherapy2 trials

RegoNivo vs Standard of Care Chemotherapy in AGOC

Active, not recruiting·AAustralasian Gastro-Intestinal Trials Group·Phase 3·NCT04879368·450 enrolled

Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy

Active, not recruiting·NNational Cancer Center Hospital East·Phase 1/2·NCT05394740·30 enrolled

Advanced Solid Tumors2 trials

A Study of CS1003 in Subjects With Advanced Solid Tumors

Completed·CCStone Pharmaceuticals·Phase 1·NCT03475251·108 enrolled

Study of Regorafenib and Sildenafil for Advanced Solid Tumors

Completed·VVirginia Commonwealth University·Phase 1·NCT02466802·32 enrolled

Cancer2 trials

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

Withdrawn·AAHS Cancer Control Alberta·Phase 1·NCT02439723

Cholangiocarcinoma2 trials

A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy

Completed·NNathan Bahary, MD·Phase 2·NCT02053376·43 enrolled

Regorafenib Versus Placebo to Treat Cholangiocarcinoma

Unknown status·EErasme University Hospital·Phase 2·NCT02162914·66 enrolled

Refractory Solid Tumors2 trials

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

Completed·CCStone Pharmaceuticals·Phase 1/2·NCT04200404·19 enrolled

Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

Completed· Bayer logo

Bayer·Phase 1·NCT01096030·33 enrolled

Rectal Cancer2 trials

A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT07223567

Neoadjuvant Regorafenib in Combination with Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer

Recruiting·JJules Bordet Institute·Phase 2·NCT04503694·72 enrolled

Colorectal Adenocarcinoma2 trials

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

Completed· Roche logo

Roche·Phase 3·NCT02788279·363 enrolled

Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

Completed·FFederation Francophone de Cancerologie Digestive·Phase 2·NCT02788006·43 enrolled

Glioblastoma2 trials

Regorafenib in Relapsed Glioblastoma

Completed·IIstituto Oncologico Veneto IRCCS·Phase 2·NCT02926222·119 enrolled

Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS

Completed·IIstituto Oncologico Veneto IRCCS··NCT04810182·192 enrolled

Unresectable2 trials

Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST

Completed·—·Phase 1·NCT02164240·14 enrolled

A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

Completed· Bayer logo

Bayer·Phase 2·NCT00664326·49 enrolled

Gastric Cancer2 trials

A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04757363·39 enrolled

FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01913639·39 enrolled

HCC2 trials

Optimization for Regorafenib in HCC

Terminated·SSC Liver Research Consortium, LLC·Phase 2·NCT04476329·7 enrolled

A Real World Study of Regogfinib in HCC

Unknown status·ZZhongda Hospital··NCT05557656·800 enrolled

Melanoma1 trial

Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy

Unknown status·YYonsei University·Phase 2·NCT02501551·36 enrolled

Maintenance Therapy1 trial

Phase II Study of Regorafenib as Maintenance Therapy

Completed·CCentre Oscar Lambret·Phase 2·NCT03793361·127 enrolled

Temozolomide1 trial

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

Completed·IIstituto Oncologico Veneto IRCCS·Phase 1·NCT06095375·21 enrolled

ctDNA1 trial

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Recruiting·UUniversity of Miami·Phase 2·NCT05366816·48 enrolled

Esophageal Cancer1 trial

A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer

Unknown status·AAustralasian Gastro-Intestinal Trials Group·Phase 3·NCT02773524·250 enrolled

Ovarian Carcinoma1 trial

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

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT02584465·68 enrolled

Advanced Malignancy1 trial

Regorafenib and Cetuximab in Patients With Advanced Malignancy

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02095054·39 enrolled

Metastatic Solid Tumors1 trial

Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy

Completed·IIstituto Clinico Humanitas·Phase 2·NCT02307500·82 enrolled

Metastatic1 trial

Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers

Terminated·UUniversity of Utah·Phase 2·NCT02241720·5 enrolled

Gastrointestinal Stromal Tumour1 trial

A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

Unknown status·AAustralasian Gastro-Intestinal Trials Group·Phase 2·NCT02365441·78 enrolled

Gastroesophageal Junction1 trial

Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery

Terminated·—·Phase 2·NCT02234180·3 enrolled

Intrahepatic Cholangiocarcinoma1 trial

Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05535647·60 enrolled

First-line1 trial

Second-line FOLFOX With or Without Regorafenib in mCRC Patients Failed to First-line Irinotecan Plus Fluoropyrimidines

Withdrawn·—·Phase 3·NCT01786538

Non-Small Cell Lung Cancer1 trial

Determination of Safety, Efficacy, and Pharmacokinetics of "Regorafenib" Combined With Pemetrexed and Cisplatin in Patients With Nonsquamous Non-Small Cell Lung Cancer

Terminated· Bayer logo

Bayer·Phase 1·NCT01187615·9 enrolled

Macular Degeneration1 trial

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

Terminated· Bayer logo

Bayer·Phase 2·NCT02222207·52 enrolled

Electroacupuncture1 trial

Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC

Recruiting·TThe First People's Hospital of Changzhou·N/A·NCT06456515·30 enrolled

Toripalimab1 trial

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

Unknown status·SSun Yat-sen University·Phase 2·NCT05485909·32 enrolled

Immune Checkpoint Inhibitor1 trial

GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.

Recruiting·—·Phase 2·NCT06558773·120 enrolled

Phase II1 trial

Phase II Study of Perindopril and Regorafenib in mCRC

Completed·BBritish Columbia Cancer Agency·Phase 2·NCT02651415·12 enrolled

Advanced Stage1 trial

Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC

Recruiting·HHumanity & Health Medical Group Limited·Phase 2·NCT03899428·30 enrolled

Sarcoma1 trial

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

Completed·SSarcoma Alliance for Research through Collaboration·Phase 2·NCT02048371·131 enrolled

Fluorouracil1 trial

Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC

Terminated·FFox Chase Cancer Center·Phase 2·NCT03099486·2 enrolled

Biliary Cancer1 trial

Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT02115542·39 enrolled

Metastatic Neuroendocrine Tumor1 trial

Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors

Completed·UUniversity of Southern California·Phase 2·NCT02259725·3 enrolled

Second-line Treatment1 trial

Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC

Unknown status·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT04718909·166 enrolled

Fatigue1 trial

Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

Unknown status·CClinical Research Support Center Kyush·Phase 2·NCT02288078·74 enrolled

Prospective1 trial

Prospective Translational Study Investigating Molecular Predictors of Resistance and Response to Regorafenib Monotherapy

Completed·RRoyal Marsden NHS Foundation Trust··NCT03010722·49 enrolled

Urothelial Cancer1 trial

Study of Regorafenib for Urothelial Cancer Following Chemotherapy (UAB 1477)

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02459119·17 enrolled

Advanced Solid Cancers1 trial

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03994601·219 enrolled

Metastasis1 trial

Sintilimab Combined With Regorafenib and HAIC in Patients With Colorectal Liver Metastasis

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05524155·30 enrolled

Monotherapy1 trial

Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC

Recruiting·FFudan University·Phase 2·NCT05970705·101 enrolled

Combination Therapy1 trial

Regorafenib and Nivolumab Simultaneous Combination Therapy

Completed·KKohei Shitara·Phase 1·NCT03406871·50 enrolled

Acute Lymphoblastic Leukemia1 trial

Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib

Terminated·WWake Forest University Health Sciences·Phase 2·NCT04327700·2 enrolled

Digestive System Cancer1 trial

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

Recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT06099821·39 enrolled

Non-metastatic Rectal Cancer1 trial

Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment

Withdrawn·RRoswell Park Cancer Institute·Phase 2·NCT02287727

Angiosarcoma1 trial

Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma

Completed·NNorthwestern University·Phase 2·NCT02048722·31 enrolled

Bevacizumab1 trial

Regorafenib After Progression on Atezolizumab Plus Bevacizumab in Advanced HCC

Unknown status·—·Phase 2·NCT05134532·40 enrolled

Myeloid Malignancies1 trial

Study of Regorafenib in Patients With Advanced Myeloid Malignancies

Completed·MMassachusetts General Hospital·Phase 1·NCT03042689·16 enrolled

Patients With Solid Tumors1 trial

Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Completed· Bayer logo

Bayer·Phase 1·NCT00960258·15 enrolled

Ewing sarcoma1 trial

Phase Ib / Regorafenib With Conventional Chemotherapy/Newly Diagnosed Patients/ Multimetastatic Ewing Sarcoma

Active, not recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1·NCT05830084·23 enrolled

Metastatic Cancer1 trial

Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer

Terminated· Bayer logo

Bayer·Phase 1·NCT02168777·20 enrolled

Cardiovascular1 trial

Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity

Completed· Bayer logo

Bayer·Phase 1·NCT01339104·53 enrolled

Meningioma1 trial

Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)

Recruiting·IIstituto Oncologico Veneto IRCCS·Phase 2·NCT06275919·104 enrolled

COVID-191 trial

An Observational Study, Called ROCURS, to Learn About COVID-19 Related Outcomes in People With Cancer Who Are Treated With Tyrosine Kinase Inhibitors (TKIs) Including Regorafenib or Sorafenib

Completed· Bayer logo

Bayer··NCT05594147·4,103 enrolled

AIN1 trial

Regorafenib Phase I Study in Mainland Chinese Patients

Completed· Bayer logo

Bayer·Phase 1·NCT02398513·18 enrolled

Solid Tumors1 trial

A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

Completed· Bayer logo

Bayer·Phase 2·NCT04704154·175 enrolled

Malignant Tumors1 trial

Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.

Completed· Bayer logo

Bayer·Phase 1·NCT02106845·42 enrolled

Recurrent or Refractory1 trial

A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy

Completed· Bayer logo

Bayer·Phase 1·NCT02085148·62 enrolled

Safety and Efficacy1 trial

The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases

Unknown status·PPeking University Cancer Hospital & Institute·Phase 2·NCT05877001·20 enrolled

mCRC1 trial

Zinc Supplement in Regorafenib Treated mCRC Patient

Completed·—·Phase 2·NCT03898102·65 enrolled

Renal Impairment1 trial

Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment

Completed· Bayer logo

Bayer·Phase 1·NCT01853046·24 enrolled

Ovarian Cancer1 trial

Use of Regorafenib in Recurrent Epithelial Ovarian Cancer

Completed·NNational Cancer Centre, Singapore·Phase 2·NCT02736305·21 enrolled

Unspecified6 trials

The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib

Completed·EErasmus Medical Center·Phase 4·NCT02800330·31 enrolled

Regorafenib Post-marketing Surveillance in Japan

Completed· Bayer logo

Bayer··NCT01933958·72 enrolled

Stivarga Real Life Evidence in Hungary

Completed· Bayer logo

Bayer··NCT02656524·400 enrolled

Show 3 more trials

Stivarga Regulatory Post-Marketing Surveillance Study in Korea

Completed· Bayer logo

Bayer··NCT02106858·316 enrolled

Regorafenib Post-marketing Surveillance

Completed· Bayer logo

Bayer··NCT01843400·1,301 enrolled

BAY73-4506 Probe Substrate Study

Completed· Bayer logo

Bayer·Phase 1·NCT01287598·41 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 27, 2012

STIVARGA

NDA NDA203085

Sep 27, 2012

STIVARGA

NDA NDA203085

Sep 13, 2013

STIVARGA

NDA NDA203085

Nov 10, 2014

STIVARGA

NDA NDA203085

Apr 13, 2015

STIVARGA

NDA NDA203085

Jun 7, 2016

STIVARGA

NDA NDA203085

Aug 26, 2016

STIVARGA

NDA NDA203085

Apr 27, 2017

STIVARGA

NDA NDA203085

Jun 14, 2018

STIVARGA

NDA NDA203085

Jul 31, 2019

STIVARGA

NDA NDA203085

Feb 13, 2020

STIVARGA

NDA NDA203085

Jul 21, 2020

STIVARGA

NDA NDA203085

Sep 24, 2020

STIVARGA

NDA NDA203085

Dec 10, 2020

STIVARGA

NDA NDA203085

Feb 25, 2025

STIVARGA

NDA NDA203085

Feb 3, 2026

STIVARGA

NDA NDA203085

Sources

References

[1]
ClinicalTrials.gov — 270 trial records for Regorafenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Stivarga drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Regorafenib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Regorafenib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203085). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Stivarga. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Regorafenib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Multi-Kinase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

Jun 2, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8680124Jun 2, 2030

8637553Feb 16, 2031

9458107Apr 8, 2031

9957232Jul 9, 2032

Key Publications[7]

Regorafenib in Refractory Metastatic Colorectal Cancer: CORRECT

Lancet OncolMar 10, 2022DOI: 10.1016/S1470-2045(22)00050-6