Clinical trial NCT03822117: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumor Malignancy
Keywords: Fibroblast growth factor receptor (FGFR) inhibitor
FGFR mutations
FGFR translocations
solid tumor malignancy
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
* Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
* Documentation of an FGFR1-3 gene mutation or translocation.
* Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Prior receipt of a selective FGFR inhibitor in the past 6 months.
* Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
* Cannot be a candidate for potentially curative surgery.
* Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
* Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
* Known additional malignancy that is progressing or requires active treatment.
* History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
* Clinically significant or uncontrolled cardiac disease.
* Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
* Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
* Known HIV infection.
* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements
timeFrame: up to 483 days
measure: ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations
timeFrame: up to 449 days
Secondary outcomes:
measure: Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
timeFrame: up to 532 days
measure: Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
timeFrame: up to 24.90 months
measure: Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
timeFrame: up to 532 days
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)
timeFrame: up to 651 days
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center University of California, Irvine
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Skokie
country: United States
facility: Edward H Kaplan & Associates
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Zion
country: United States
facility: Cancer Treatment Centers of America
state: Illinois
city: Lafayette
country: United States
facility: Indiana University Health - Arnett Cancer Care
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Umass Memorial Medical Center, Inc.
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center
state: Oklahoma
city: Greenville
country: United States
facility: Cancer Institute of Greenville Health System
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic Pc
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, Pc
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates-Lake Wright
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute For Research & Innovation
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals Inc
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Copenhagen
country: Denmark
facility: The Finsen Centre National Hospital
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon Cedex
country: France
facility: CENTRE GEORGES FRANï¿½OIS LECLERC
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hospital Saint Louis
city: Paris
country: France
facility: A.P.H. Paris Hopital Cochin
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer de Toulouse Oncopole
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Hamburg
country: Germany
facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology
city: Koln
country: Germany
facility: Universitatsklinikum Koln
city: Munich
country: Germany
facility: University Hospital Grosshadern Munich
city: Tubingen
country: Germany
facility: Universitaetsklinikum in Tubingen
city: Afula
country: Israel
facility: Ha Emek Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bologna
country: Italy
facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione Pascale
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena Irccs
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona (Crc)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal (Ciocc)
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra (Cun)
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital Universitario Y Politcnico de La Fe
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: Zuerich
country: Switzerland
facility: Universitatsspital Zurich
city: London
country: United Kingdom
facility: University College London Hospitals (Uclh)
city: London
country: United Kingdom
facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
Study officials:
affiliation: Incyte Corporation
name: Peter Langmuir, MD
role: STUDY_DIRECTOR
References: