Clincosm LogoSign in Get a demo

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02924376
Collaborator
(none)
147
Enrollment
120
Locations
3
Arms
60.5
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 evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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 Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)
Actual Study Start Date :
Jan 16, 2017
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A Pemigatinib

Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report

Drug: Pemigatinib
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Other Names:
  • INCB054828

    		•
    Experimental: Cohort B Pemigatinib

    Pemigatinibin subjects with other FGF/FGFR alterations

    Drug: Pemigatinib
    Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
    Other Names:
  • INCB054828

    		•
    Experimental: Cohort C Pemigatinib

    Pemigatinib in subjects negative for FGF/FGFR alteration

    Drug: Pemigatinib
    Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
    Other Names:
  • INCB054828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) in subjects with FGFR2 translocations based on RECIST v1.1 [Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months.]

      ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.

    Secondary Outcome Measures

    1. ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 [Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months]

      ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.

    2. Progression-free survival based on RECIST v1.1 [Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months.]

      Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.

    3. Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events [From screening through 30-35 days after end of treatment, up to 6 months.]

    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 cholangiocarcinoma.

    • Radiographically measurable or evaluable disease per RECIST v1.1.

    • Tumor assessment for FGF/FGFR gene alteration status.

    • Documented disease progression after at least 1 line of prior systemic therapy.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

    • Life expectancy ≥ 12 weeks.

    Exclusion Criteria:

    • Prior receipt of a selective FGFR inhibitor.

    • History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.

    • Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.

    • 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. Topical ketoconazole will be allowed.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Alaska United States
    2 Phoenix Arizona United States
    3 Tempe Arizona United States
    4 Tucson Arizona United States
    5 Orange California United States
    6 San Francisco California United States
    7 Aurora Colorado United States
    8 Denver Colorado United States
    9 New Haven Connecticut United States
    10 Newark Delaware United States
    11 Washington District of Columbia United States
    12 Gainesville Florida United States
    13 Miami Beach Florida United States
    14 Chicago Illinois United States
    15 Evanston Illinois United States
    16 Fort Wayne Indiana United States
    17 Sioux City Iowa United States
    18 Westwood Kansas United States
    19 Louisville Kentucky United States
    20 Baltimore Maryland United States
    21 Ann Arbor Michigan United States
    22 Detroit Michigan United States
    23 Rochester Minnesota United States
    24 Woodbury Minnesota United States
    25 Saint Louis Missouri United States
    26 Billings Montana United States
    27 Omaha Nebraska United States
    28 Morristown New Jersey United States
    29 New York New York United States
    30 Rochester New York United States
    31 Charlotte North Carolina United States
    32 Goldsboro North Carolina United States
    33 Cincinnati Ohio United States
    34 Cleveland Ohio United States
    35 Portland Oregon United States
    36 Philadelphia Pennsylvania United States
    37 Pittsburgh Pennsylvania United States
    38 Sioux Falls South Dakota United States
    39 Arlington Texas United States
    40 Dallas Texas United States
    41 Grapevine Texas United States
    42 San Antonio Texas United States
    43 The Woodlands Texas United States
    44 Tyler Texas United States
    45 Waco Texas United States
    46 Salt Lake City Utah United States
    47 Fairfax Virginia United States
    48 Seattle Washington United States
    49 Madison Wisconsin United States
    50 Brussels Belgium
    51 Gent Belgium
    52 Kortrijk Belgium
    53 Leuven Belgium
    54 Montpellier Herault France
    55 Villejuif Herault France
    56 Avignon France
    57 Clichy France
    58 Paris France
    59 Toulouse France
    60 Berlin Germany
    61 Bonn Germany
    62 Dresden Germany
    63 Hannover Germany
    64 Homburg Germany
    65 Leipzig Germany
    66 Mainz Germany
    67 Tuebingen Germany
    68 Jerusalem Israel
    69 Petach Tikva Israel
    70 Ramat Gan Israel
    71 Tel Aviv Israel
    72 Bari Castellana Grotte Italy
    73 San Giovanni Rotondo Foggia Italy
    74 Bergamo Italy
    75 Bologna Italy
    76 Candiolo Italy
    77 Catania Italy
    78 Faenza Italy
    79 Lecce Italy
    80 Meldola Italy
    81 Milano Italy
    82 Napoli Italy
    83 Rimini Italy
    84 Siena Italy
    85 Verona Italy
    86 Nagoya-shi Aichi-Ken Japan
    87 Chiba-shi Chiba-Ken Japan
    88 Fukuoka-shi Fukuoka-Ken Japan
    89 Yokohama-shi Kanagawa-Ken Japan
    90 Kyoto-shi Kyoto-Fu Japan
    91 Osaka-shi Osaka-Fu Japan
    92 Osakasayama-shi Osaka-Fu Japan
    93 Kitaadachi Saitama-Ken Japan
    94 Sunto Shizuoka-Ken Japan
    95 Koto-ku Tokyo-To Japan
    96 Shinjuku-ku Tokyo-To Japan
    97 Goyang-si Korea, Republic of
    98 Seongnam-si Korea, Republic of
    99 Seoul Korea, Republic of
    100 Pamplona Navarra Spain
    101 Barcelona Spain
    102 Girona Spain
    103 Madrid Spain
    104 Taichung Taiwan
    105 Tainan Taiwan
    106 Taipei Taiwan
    107 Chiang Mai Muang Thailand
    108 Khon Kaen Muang Thailand
    109 Udon Thani Muang Thailand
    110 Bangkok Patumwan Thailand
    111 Bangkoknoi Thailand
    112 Cambridge Cambridgeshire United Kingdom
    113 Bournemouth Dorset United Kingdom
    114 Aberdeen Grampian Region United Kingdom
    115 London Greater London United Kingdom
    116 Cardiff United Kingdom
    117 Glasgow United Kingdom
    118 Manchester United Kingdom
    119 Sheffield United Kingdom
    120 Wirral United Kingdom

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Luis Féliz Vinas, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02924376
    Other Study ID Numbers:
    • INCB 54828-202
    First Posted:
    Oct 5, 2016
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Incyte Corporation
    Cholangiocarcinoma
    fibroblast growth factor (FGF)
    fibroblast growth factor receptor (FGFR)
    FGF/FGFR alterations
    Additional relevant MeSH terms:
    Cholangiocarcinoma

    Study Results

    No Results Posted as of Apr 5, 2022