Pemigatinib

Generic Name: Pemigatinib

Brand Names: Pemazyre

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₇F_₂N_₅O_₄

CAS Number: 1513857-77-6

Unique Ingredient Identifier: Y6BX7BL23K

Background: Pemigatinib is a small molecule kinase inhibitor with antitumour activity. It works by inhibiting fibroblast growth factor receptors (FGFRs), which are receptor tyrosine kinases that activate signalling pathways in tumour cells. FGFRs gained attention as potential therapeutic targets in selected cancers, as FGFR gene alterations were observed in a wide varie...

Indication: Pemigatinib is indicated for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in previously-treated adult patients with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
...

Associated Conditions: Refractory Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement, Relapsed Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement, Unresectable, locally advanced Cholangiocarcinomas, Unresectable, metastatic Cholangiocarcinomas

Associated Therapies: -

Clinical Trials

Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspirate
Procedure: Bone Marrow Biopsy
Drug: Cytarabine
Drug: Daunorubicin
Procedure: Electrocardiography
Drug: Pemigatinib

First Posted Date: 2020-12-09

Last Posted Date: 2024-12-10

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 32

Registration Number: NCT04659616

Locations: 🇺🇸
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

First Posted Date: 2020-10-19

Last Posted Date: 2023-10-03

Lead Sponsor: Fondazione per la Medicina Personalizzata

Target Recruit Count: 400

Registration Number: NCT04591431

Locations: 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹
Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹
I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy

and more 34 locations

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

Phase 2

Recruiting

Conditions: Endometrial Cancer

Interventions: Drug: retifanlimab
Drug: INCAGN02385
Drug: epacadostat
Drug: INCAGN02390
Drug: pemigatinib

First Posted Date: 2020-07-09

Last Posted Date: 2024-06-24

Lead Sponsor: Incyte Corporation

Target Recruit Count: 300

Registration Number: NCT04463771

Locations: 🇺🇸
Advent Health Medical Group-Orlando 2501, Orlando, Florida, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa, Florida, United States
🇺🇸
Alaska Womens Cancer Care Akwcc, Anchorage, Alaska, United States

and more 62 locations

Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery

Phase 2

Terminated

Conditions: Urothelial Cancer

Interventions: Drug: Pemigatinib

First Posted Date: 2020-03-04

Last Posted Date: 2023-02-14

Lead Sponsor: European Association of Urology Research Foundation

Target Recruit Count: 2

Registration Number: NCT04294277

Locations: 🇮🇹
IRCCS San Raffaele Hospital, Milano, Italy
🇮🇹
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy
🇮🇹
ASST Papa Giovanni XXIII, Bergamo, Italy

and more 2 locations

Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

Phase 1

Completed

Conditions: Solid Tumor

Interventions: Drug: Pemigatinib

First Posted Date: 2020-02-06

Last Posted Date: 2021-07-23

Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Target Recruit Count: 12

Registration Number: NCT04258527

Locations: 🇨🇳
Cancer Hospital of Tianjin Medical University, Tianjin, China

Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement

Phase 2

Completed

Conditions: Cholangiocarcinoma

Interventions: Drug: Pemigatinib

First Posted Date: 2020-02-05

Last Posted Date: 2024-05-30

Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Target Recruit Count: 34

Registration Number: NCT04256980

Locations: 🇨🇳
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China

Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

Phase 2

Active, not recruiting

Conditions: FGFR1 Gene Amplification
FGFR1 Gene Mutation
FGFR1 Gene Translocation
FGFR2 Gene Amplification
FGFR2 Gene Mutation
FGFR2 Gene Translocation
FGFR3 Gene Amplification
FGFR3 Gene Mutation
FGFR3 Gene Translocation
Metastatic Colorectal Carcinoma

Interventions: Drug: Pemigatinib
Other: Quality-of-Life Assessment

First Posted Date: 2019-09-19

Last Posted Date: 2024-02-21

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 14

Registration Number: NCT04096417

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 3 locations

Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma

Phase 1

Terminated

Conditions: Unresectable Cholangiocarcinoma
Advanced Cholangiocarcinoma
Metastatic Cholangiocarcinoma

Interventions: Drug: Cisplatin
Drug: Gemcitabine
Drug: Ivosidenib
Drug: Pemigatinib

First Posted Date: 2019-09-12

Last Posted Date: 2024-05-06

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 8

Registration Number: NCT04088188

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 4 locations

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

Phase 2

Terminated

Conditions: Unresectable Urothelial Carcinoma
Metastatic Urothelial Carcinoma

Interventions: Drug: Pemigatinib
Drug: Gemcitabine
Drug: Pembrolizumab
Drug: Carboplatin

First Posted Date: 2019-07-01

Last Posted Date: 2022-05-26

Lead Sponsor: Incyte Corporation

Target Recruit Count: 7

Registration Number: NCT04003610

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States
🇺🇸
The University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
Mount Sinai School of Medicine, New York, New York, United States

and more 76 locations

Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

Phase 2

Terminated

Conditions: Advanced or Metastatic Solid Tumors
FGFR Translocations
FGFR Mutations

Interventions: Drug: Pemigatinib

First Posted Date: 2019-07-01

Last Posted Date: 2022-05-10

Lead Sponsor: Incyte Corporation

Target Recruit Count: 1

Registration Number: NCT04003623

Locations: 🇺🇸
Hawaii Cancer Care, Honolulu, Hawaii, United States
🇺🇸
FMH James M Stockman Cancer Institute, Frederick, Maryland, United States
🇺🇸
Ocala Oncology Center, Ocala, Florida, United States

and more 8 locations

Drug Development Updates

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