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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)

Sponsor
Incyte Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT03822117
Collaborator
(none)
111
Enrollment
90
Locations
1
Arm
29.4
Actual Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 17, 2019
Actual Primary Completion Date :
Mar 29, 2022
Actual Study Completion Date :
Mar 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pemigatinib

Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)). *Only FGFR fusions or rearrangements with an intact kinase domain are eligible

Drug: Pemigatinib
Pemigatinib administered orally once daily (QD).
Other Names:
  • INCB054828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) in Cohort A [Up to approximately 6 months]

      Defined as the proportion of participants in Cohort A who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) as determined by an independent radiological review committee.

    2. ORR in Cohort B [Up to approximately 6 months]

      Defined as the proportion of participants in Cohort B who achieve a CR or PR based on RECIST v1.1 or RANO as determined by an independent radiological review committee.

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [Up to approximately 6 months]

      Defined as the time from first dose until progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.

    2. Duration of response (DOR) [Up to approximately 6 months]

      Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.

    3. Overall survival (OS) [Up to approximately 6 months]

      Defined as the time from first dose of study drug to death of any cause in Cohorts A and B, respectively.

    4. Number of treatment-emergent adverse events [Up to approximately 6 months]

      Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    5. Number of treatment-related adverse events. [Up to approximately 6 months]

      Adverse events considered to be treatment-related by the investigator.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Treatment Centers of America Goodyear Arizona United States 85338
    2 Mayo Clinic Hospital Phoenix Arizona United States 85054
    3 The University of Arizona Cancer Center Tucson Arizona United States 85724
    4 Chao Family Comprehensive Cancer Center University of California, Irvine Orange California United States 92868
    5 Stanford Cancer Center Palo Alto California United States 94304
    6 John Wayne Cancer Institute Santa Monica California United States 90404
    7 St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    8 Florida Cancer Specialists & Research Institute Fort Myers Florida United States 33901
    9 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    10 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    11 Florida Cancer Specialists Tallahassee Florida United States 32308
    12 Florida Cancer Specialists West Palm Beach Florida United States 33401
    13 Illinois Cancer Specialists Arlington Heights Illinois United States 60005
    14 Edward H Kaplan & Associates Skokie Illinois United States 60076
    15 Carle Cancer Center Urbana Illinois United States 61801
    16 Cancer Treatment Centers of America Zion Illinois United States 60099
    17 Indiana University Health - Arnett Cancer Care Lafayette Indiana United States 47904
    18 University of Iowa Iowa City Iowa United States 52242
    19 University of Kansas Cancer Center Westwood Kansas United States 66205
    20 Ochsner Clinic New Orleans Louisiana United States 70121
    21 Central Maine Medical Center Lewiston Maine United States 04240
    22 Massachusetts General Hospital Boston Massachusetts United States 02114
    23 Umass Memorial Medical Center, Inc. Worcester Massachusetts United States 01655
    24 Mayo Clinic Rochester Rochester Minnesota United States 55905
    25 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    26 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    27 Summit Medical Group Florham Park New Jersey United States 07932
    28 Winthrop University Hospital Mineola New York United States 11501
    29 Oncology Specialists of Charlotte Charlotte North Carolina United States 28204
    30 Duke Cancer Center Durham North Carolina United States 27710
    31 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157
    32 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    33 Southwestern Regional Medical Center Tulsa Oklahoma United States 74133
    34 Cancer Institute of Greenville Health System Greenville South Carolina United States 29605
    35 The West Clinic Pc Germantown Tennessee United States 38138
    36 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    37 Houston Methodist Hospital Houston Texas United States 77030
    38 Joe Arrington Cancer Center Lubbock Texas United States 79410
    39 Virginia Cancer Specialists, Pc Fairfax Virginia United States 22031
    40 Virginia Oncology Associates-Lake Wright Norfolk Virginia United States 23502
    41 Seattle Cancer Care Alliance Seattle Washington United States 98109
    42 Multicare Institute For Research & Innovation Tacoma Washington United States 98405
    43 West Virginia University Hospitals Inc Morgantown West Virginia United States 26506
    44 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    45 The Finsen Centre National Hospital Copenhagen Denmark 02100
    46 Institut Bergonie Bordeaux France 33000
    47 CENTRE GEORGES FRAN�OIS LECLERC Dijon Cedex France 21079
    48 Centre Antoine Lacassagne Nice France 06189
    49 Hospital Saint Louis Paris France 75010
    50 A.P.H. Paris Hopital Cochin Paris France 75014
    51 Institut Universitaire Du Cancer de Toulouse Oncopole Toulouse France 31059
    52 University Medical Center Freiburg Freiburg Germany 79106
    53 University Medical Centre Hamburg-Eppendorf, Centre of Oncology Hamburg Germany 20246
    54 Universitatsklinikum Koln Koln Germany 50937
    55 University Hospital Grosshadern Munich Munich Germany 81377
    56 Universitaetsklinikum in Tubingen Tubingen Germany 72076
    57 Ha Emek Medical Center Afula Israel 18101
    58 Rambam Health Care Campus Haifa Israel 3525408
    59 Hadassah Hebrew University Medical Center Ein Karem Hadassah Jerusalem Israel 90000
    60 Rabin Medical Center - Beilinson Hospital Petach Tikva Israel 4841492
    61 Assaf Harofeh Medical Center Zerifin Israel 7030000
    62 L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI Bologna Italy 40138
    63 Fondazione Del Piemonte Per L Oncologia Ircc Candiolo Candiolo Italy 10060
    64 Fondazione Irccs Istituto Nazionale Dei Tumori Milan Italy 20133
    65 Istituto Nazionale Tumori Irccs Fondazione Pascale Napoli Italy 80131
    66 Istituto Nazionale Tumori Regina Elena Irccs Roma Italy 00144
    67 Centro Ricerche Cliniche Di Verona (Crc) Verona Italy 37134
    68 National Hospital Organization Kyushu Cancer Center Fukuoka Japan 811-1395
    69 Kanazawa University Hospital Ishikawa Japan 920-8641
    70 Kobe University Hospital Kobe Japan 650-0017
    71 Tohoku University Hospital Sendai-shi Japan 980-8574
    72 Keio University Hospital Shinjuku-ku Japan 160-8582
    73 Shizuoka Cancer Center Shizuoka Japan 411-8777
    74 Kanagawa Cancer Center Yokohama-shi Japan 241-8515
    75 National Cancer Center Goyang-si Korea, Republic of 10408
    76 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    77 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 03722
    78 Samsung Medical Center Seoul Korea, Republic of 06351
    79 Hospital General Universitario Vall D Hebron Barcelona Spain 08035
    80 Hospital Clinic I Provincial Barcelona Spain 08036
    81 Centro Integral Oncologico Clara Campal (Ciocc) Madrid Spain 28050
    82 Hospital Regional Universitario de Malaga Malaga Spain 29010
    83 Clinica Universidad de Navarra (Cun) Pamplona Spain 31008
    84 Hospital Universitario Marques de Valdecilla Santander Spain 39008
    85 Hospital Universitario Y Politcnico de La Fe Valencia Spain 46026
    86 Inselspital - Universitaetsspital Bern Bern Switzerland 03010
    87 Universitatsspital Zurich Zuerich Switzerland 08091
    88 University College London Hospitals (Uclh) London United Kingdom NW1 2PG
    89 Imperial College Healthcare Nhs Trust - Hammersmith Hospital London United Kingdom W12 0HS
    90 Sarah Cannon Research Institute London United Kingdom W1G 6AD

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Peter Langmuir, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03822117
    Other Study ID Numbers:
    • INCB 54828-207
    First Posted:
    Jan 30, 2019
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Fibroblast growth factor receptor (FGFR) inhibitor
    FGFR mutations
    FGFR translocations
    solid tumor malignancy
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jun 21, 2022