Cholangiocarcinoma

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Incyte Study ID:
INCB 54828-302
CT.gov ID:
NCT03656536
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Cholangiocarcinoma
    • PRODUCT
  • Drug: Pemigatinib
  • Drug: Gemcitabine
  • Drug: Cisplatin
    • COLLABORATORS
    N/A
    DATE
    Jun 2019 - Oct 2027
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF).
    • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).

    Exclusion Criteria

    • Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least 14 days and ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).
    • Child-Pugh B and C.

    Clinical Study Locations

    Location
    Status
    Location
    MAYO CLINIC ARIZONA
    PHOENIX, AZ, US, 85054
    Status
    Recruiting
    Location
    KARMANOS CANCER INSTITUTE
    FARMINGTON HILLS, MI, US, 48334
    Status
    Recruiting
    Location
    GEORGETOWN UNIVERSITY-LOMBARDI COMPREHENSIVE CANCER CENTER
    WASHINGTON, DC, US, 20007
    Status
    Completed
    Location
    MAYO CLINIC-FLORIDA
    JACKSONVILLE, FL, US, 32224
    Status
    Recruiting
    Location
    MOUNT SINAI MEDICAL CENTER COMPREHENSIVE CANCER CENTER
    MIAMI BEACH, FL, US, 33140
    Status
    Recruiting
    Location
    WINSHIP CANCER INSTITUTE OF EMORY UNIVERSITY
    ATLANTA, GA, US, 30322
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 54828-302
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    167
    Primary Outcome
    Open

    Progression-free survival

    Timeframe: Up to approximately 12 months

    Secondary Outcome
    Open

    Overall response rate

    Timeframe: Up to approximately 12 months

    Overall survival

    Timeframe: Up to approximately 12 months

    Duration of response

    Timeframe: Up to approximately 12 months

    Disease control rate

    Timeframe: Up to approximately 12 months

    Number of treatment-emergent adverse events

    Timeframe: Up to approximately 12 months

    Quality of Life impact as assessed by the EQ-5D-3L questionnaire

    Timeframe: Up to 12 months

    Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire

    Timeframe: Up to 12 months

    Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire

    Timeframe: Up to 12 months