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Rogaratinib

Generic Name
Rogaratinib
Drug Type
Small Molecule
Chemical Formula
C23H26N6O3S
CAS Number
1443530-05-9
Unique Ingredient Identifier
98BSN6N516
Background

Rogaratinib is under investigation in clinical trial NCT03762122 (Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC)).

Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)

Phase 2
Active, not recruiting
Conditions
Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8
Stage III Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8
Locally Advanced Gastrointestinal Stromal Tumor
Locally Advanced Sarcoma
Metastatic Gastrointestinal Stromal Tumor
Metastatic Sarcoma
Stage III Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8
Stage IV Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
First Posted Date
2020-10-22
Last Posted Date
2025-05-22
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
48
Registration Number
NCT04595747
Locations
🇺🇸

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

and more 15 locations

Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

Phase 2
Completed
Conditions
Cancer
Interventions
Drug: Combination drug
First Posted Date
2019-10-14
Last Posted Date
2022-04-01
Lead Sponsor
Bayer
Target Recruit Count
1
Registration Number
NCT04125693
Locations
🇨🇭

Kantonsspital St. Gallen, St. Gallen, Sankt Gallen, Switzerland

Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression

Phase 2
Withdrawn
Conditions
Bladder Cancer
Interventions
First Posted Date
2019-08-01
Last Posted Date
2019-12-17
Lead Sponsor
Dana-Farber Cancer Institute
Registration Number
NCT04040725

Rogaratinib (BAY1163877) in Chinese Patients

Phase 1
Completed
Conditions
Neoplasms
Interventions
First Posted Date
2018-12-27
Last Posted Date
2021-03-29
Lead Sponsor
Bayer
Target Recruit Count
1
Registration Number
NCT03788603
Locations
🇨🇳

Beijing Hospital, Beijing, China

Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC)

Phase 2
Terminated
Conditions
Squamous-cell Non-small Cell Lung Cancer
Interventions
First Posted Date
2018-12-03
Last Posted Date
2022-11-09
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
15
Registration Number
NCT03762122
Locations
🇨🇭

Universitaetsspital Basel, Basel, Switzerland

🇨🇭

IOSI Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland

🇨🇭

Kantonsspital Baselland Bruderholz, Bruderholz, Switzerland

and more 8 locations

Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

Phase 1
Completed
Conditions
Advanced or Metastatic Solid Tumor
Interventions
First Posted Date
2018-05-08
Last Posted Date
2022-07-14
Lead Sponsor
Bayer
Target Recruit Count
16
Registration Number
NCT03517956
Locations
🇺🇸

University of Maryland, Baltimore, Maryland, United States

🇸🇬

National University Hospital, Singapore, Singapore

🇪🇸

Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, Spain

and more 17 locations

Rogaratinib (BAY1163877) Human Mass Balance Study

Phase 1
Completed
Conditions
Clinical Trial, Phase I
Pharmacokinetics
Interventions
First Posted Date
2018-04-02
Last Posted Date
2018-08-14
Lead Sponsor
Bayer
Target Recruit Count
6
Registration Number
NCT03484585
Locations
🇳🇱

PRAHealthSciences, Groningen, Netherlands

Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

Phase 1
Completed
Conditions
Urothelial Carcinoma
Interventions
First Posted Date
2018-03-22
Last Posted Date
2025-04-09
Lead Sponsor
Bayer
Target Recruit Count
37
Registration Number
NCT03473756
Locations
🇺🇸

UChicago Medicine Comprehensive Cancer Center - Hyde Park, Chicago, Illinois, United States

🇺🇸

Barbara Ann Karmanos Cancer Institute - Detroit Headquarters, Detroit, Michigan, United States

🇫🇷

Institut Bergonie - Unicancer Nouvelle Aquitaine, Bordeaux Cedex, France

and more 27 locations

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

Phase 2
Completed
Conditions
Carcinoma, Transitional Cell
Interventions
First Posted Date
2018-01-25
Last Posted Date
2022-09-28
Lead Sponsor
Bayer
Target Recruit Count
175
Registration Number
NCT03410693
Locations
🇺🇸

Summit Cancer Center, Spokane, Washington, United States

🇨🇦

Princess Margaret Hospital-University Health Network, Toronto, Ontario, Canada

🇨🇳

Jiangsu Cancer Hospital, Nanjing, Jiangsu, China

and more 158 locations

Phase I Dose Escalation Study of BAY 1163877 (Rogaratinib) in Japanese Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors

Phase 1
Completed
Conditions
Neoplasms
Interventions
First Posted Date
2015-10-30
Last Posted Date
2018-04-18
Lead Sponsor
Bayer
Target Recruit Count
9
Registration Number
NCT02592785
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