A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
- Registration Number
- NCT02872714
- Lead Sponsor
- Incyte Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A-ID (Intermittent Dose) Pemigatinib pemigatinib Pemigatinib in subjects with FGFR3 mutations or fusions. Cohort A-CD (Continuous Dose) Pemigatinib pemigatinib Pemigatinib in subjects with FGFR3 mutations or fusions. Cohort B Pemigatinib pemigatinib Pemigatinib in subjects with other FGF/FGFR alterations.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen up to 1138 days 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.
- Secondary Outcome Measures
Name Time Method ORR in Participants With All Other FGF/FGFR Alterations up to 1198 days 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.
ORR in All Participants on an ID or CD Regimen in Combined Cohorts up to 1198 days 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.
Overall Survival up to 1610 days 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.
Duration of Response (DOR) up to 1075 days 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
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen up to 817 days 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.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) up to approximately 25 weeks 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.
Progression-free Survival (PFS) up to 1138 days 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.
Trial Locations
- Locations (96)
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, Germany
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, Israel
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
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
University Campus Bio-Medico di Roma
🇮🇹Rome, Italy
Kyushu University Hospital
🇯🇵Fukuoka-shi, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Japan
Hirosaki University Hospital
🇯🇵Hirosaki-shi, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
Osaka University Hospital
🇯🇵Suita-shi, Japan
HagaZiekenhuis Van Den Haag
🇳🇱Den Haag, Netherlands
Zorgsaam Ziekenhuis
🇳🇱Terneuzen, Netherlands
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Viecuri Medisch Centrum
🇳🇱Venlo, Netherlands
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
University College London Hospitals
🇬🇧London, Greater London, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Strathclyde, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
University of Maryland, Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Baylor Scott & White Health
🇺🇸Temple, Texas, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Woodbury, Minnesota, United States
Calaway-Young Cancer Center at Valley View Hospital
🇺🇸Glenwood Springs, Colorado, United States
University of Rochester
🇺🇸Rochester, New York, United States
UZ Antwerpen
🇧🇪Edegem, Belgium
Arizona Oncology Associates (Wilmot)
🇺🇸Tucson, Arizona, United States
TRIO - Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Rocky Mountain Cancer Centers
🇺🇸Boulder, Colorado, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Lahey Clinic Inc. - PARENT ACCOUNT
🇺🇸Burlington, Massachusetts, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
GU Research Network
🇺🇸Omaha, Nebraska, United States
Compass Oncology the Northwest Cancer Specialists
🇺🇸Tualatin, Oregon, United States
CHU Strasbourg - Nouvel Hôpital Civil
🇫🇷Strasbourg, Rhone, France
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Hopital Saint Louis
🇫🇷Paris Cedex 10, Paris, France
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Groupe Hospitalier Saint André - Hôpital Saint André
🇫🇷Bordeaux cedex, Gironde, France
ICO - Site René Gauducheau
🇫🇷Saint Herblain, Loire Atlantique, France
Centre Leon Berard
🇫🇷Lyon Cedex 8, Rhone, France
AZ Sint-Lucas - Campus Sint-Lucas
🇧🇪Gent, Belgium
AZ Groeninge Campus Loofstraat
🇧🇪Kortrijk, Belgium
ICO - Site Paul Papin
🇫🇷Angers Cedex 9, Maine Et Loire, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Nottingham University Hospitals City Campus
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Institut Claudius Regaud-Oncopole
🇫🇷Toulouse cedex 09, Haute Garonne, France
Ospedale degli Infermi
🇮🇹Rimini, Italy
Nara Medical University Hospital
🇯🇵Kashihara-shi, Japan
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio
🇮🇹Napoli, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
San Camillo-Forlanini Hospital
🇮🇹Siena, Italy
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Japan
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
UCSF Helen Diller Family Comprehensive Care Center
🇺🇸San Francisco, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Northwell Cancer Institute
🇺🇸New Hyde Park, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Oncology, P.A. - Austin
🇺🇸Austin, Texas, United States
Texas Oncology
🇺🇸Houston, Texas, United States
Texas Oncology - Baylor Charles A. Sammons
🇺🇸Dallas, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Texas Oncology, P.A. - Sherman
🇺🇸Sherman, Texas, United States
Virginia Oncology Associates - Hampton
🇺🇸Norfolk, Virginia, United States
Rigshospitalet
🇩🇰Copenhagen, Denmark
Northwest Medical Specialties, PLLC
🇺🇸Tacoma, Washington, United States
AZ Delta
🇧🇪Roeselare, Belgium
CHU Besançon - Hôpital Jean Minjoz
🇫🇷Besancon Cedex, Doubs, France
Groupe Hospitalier Pitie-Salpetriere
🇫🇷Paris, France
University of Wisconsic Hospital and Clinic
🇺🇸Madison, Wisconsin, United States
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Guy's Hospital
🇬🇧London, Greater London, United Kingdom
Charing Cross Hospital
🇬🇧London, Greater London, United Kingdom