A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

UC (Urothelial Cancer) Clinical Trial

Official title:

A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872714
• Other study ID #: INCB 54828-201
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2017
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2023
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 20 years and older in Japan
• Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Life expectancy = 12 weeks.
• Radiographically measurable per RECIST v1.1.
• Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.

Exclusion Criteria:

• Prior receipt of a selective FGFR inhibitor.
• Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
• Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• UC (Urothelial Cancer)

Intervention

Drug:
• pemigatinib
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
• pemigatinib
Pemigatinib once a day by mouth continuously.

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Edegem
Belgium	AZ Sint-Lucas - Campus Sint-Lucas	Gent
Belgium	AZ Groeninge Campus Loofstraat	Kortrijk
Belgium	AZ Delta	Roeselare
Denmark	Rigshospitalet	Copenhagen
France	ICO - Site Paul Papin	Angers Cedex 9	Maine Et Loire
France	CHU Besançon - Hôpital Jean Minjoz	Besancon Cedex	Doubs
France	Groupe Hospitalier Saint André - Hôpital Saint André	Bordeaux cedex	Gironde
France	Centre Leon Berard	Lyon Cedex 8	Rhone
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hopital Saint Louis	Paris Cedex 10	Paris
France	ICO - Site René Gauducheau	Saint Herblain	Loire Atlantique
France	CHU Strasbourg - Nouvel Hôpital Civil	Strasbourg	Rhone
France	Institut Claudius Regaud-Oncopole	Toulouse cedex 09	Haute Garonne
France	Institut Gustave Roussy	Villejuif
Germany	Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berlin
Germany	Klinikum Dresden Standort Dresden-Friedrichstadt	Dresden
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Studienpraxis Urologie Drs. Feyerabend	Nürtingen
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Assaf Harofeh Medical Center	Be'er Ya'aqov
Israel	Meir Medical Center	Kfar-Saba
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Bologna
Italy	Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo	Candiolo
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio	Napoli
Italy	Ospedale degli Infermi	Rimini
Italy	University Campus Bio-Medico di Roma	Rome
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena
Italy	San Camillo-Forlanini Hospital	Siena
Japan	Kyushu University Hospital	Fukuoka-shi
Japan	Saitama Medical University International Medical Center	Hidaka-shi
Japan	Hirosaki University Hospital	Hirosaki-shi
Japan	Nihon University Itabashi Hospital	Itabashi-ku
Japan	Teikyo University Hospital	Itabashi-ku
Japan	Nara Medical University Hospital	Kashihara-shi
Japan	Osaka International Cancer Institute	Osaka-shi
Japan	Saitama Cancer Center	Saitama
Japan	Osaka University Hospital	Suita-shi
Japan	Jichi Medical University Hospital	Tochigi
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	HagaZiekenhuis Van Den Haag	Den Haag
Netherlands	Zorgsaam Ziekenhuis	Terneuzen
Netherlands	Viecuri Medisch Centrum	Venlo
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta	Girona
Spain	Centro Integral Oncologico Clara Campal	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
United Kingdom	Queen Elizabeth Hospital	Birmingham	West Midlands
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Strathclyde
United Kingdom	Charing Cross Hospital	London	Greater London
United Kingdom	Guy's Hospital	London	Greater London
United Kingdom	University College London Hospitals	London	Greater London
United Kingdom	Nottingham University Hospitals City Campus	Nottingham	Nottinghamshire
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Texas Oncology, P.A. - Austin	Austin	Texas
United States	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland
United States	St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Lahey Clinic Inc. - PARENT ACCOUNT	Burlington	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Texas Oncology - Baylor Charles A. Sammons	Dallas	Texas
United States	Calaway-Young Cancer Center at Valley View Hospital	Glenwood Springs	Colorado
United States	Texas Oncology	Houston	Texas
United States	TRIO - Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	University of Wisconsic Hospital and Clinic	Madison	Wisconsin
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Northwell Cancer Institute	New Hyde Park	New York
United States	Virginia Oncology Associates - Hampton	Norfolk	Virginia
United States	GU Research Network	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	UCSF Helen Diller Family Comprehensive Care Center	San Francisco	California
United States	Texas Oncology, P.A. - Sherman	Sherman	Texas
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington
United States	Baylor Scott & White Health	Temple	Texas
United States	Compass Oncology the Northwest Cancer Specialists	Tualatin	Oregon
United States	Arizona Oncology Associates (Wilmot)	Tucson	Arizona
United States	Minnesota Oncology Hematology, P.A.	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen	ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.	up to 1138 days
Secondary	ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen	ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.	up to 817 days
Secondary	ORR in Participants With All Other FGF/FGFR Alterations	ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.	up to 1198 days
Secondary	ORR in All Participants on an ID or CD Regimen in Combined Cohorts	ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.	up to 1198 days
Secondary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.	up to approximately 25 weeks
Secondary	Progression-free Survival (PFS)	PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.	up to 1138 days
Secondary	Duration of Response (DOR)	DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed	up to 1075 days
Secondary	Overall Survival	Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.	up to 1610 days