Small Cell Lung Cancer, Advanced/Metastatic, Stomach or Esophageal Cancer, Bladder Cancer, Genitourinary & Gynecologic Cancer, Myeloma, Myeloproliferative neoplasms (MPN), Breast Cancer, Cholangiocarcinoma

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Incyte Study ID:
INCB 54828-101
CT.gov ID:
NCT02393248
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1-855-463-3463
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Small Cell Lung Cancer
  • Advanced/Metastatic
  • Stomach or Esophageal Cancer
  • Bladder Cancer
  • Genitourinary & Gynecologic Cancer
  • Myeloma
  • Myeloproliferative neoplasms (MPN)
  • Breast Cancer
  • Cholangiocarcinoma
    • PRODUCT
  • Drug: Pemigatinib
  • Drug: Gemcitabine
  • Drug: Pembrolizumab
  • Drug: Docetaxel
  • Drug: Trastuzumab
  • Drug: Retifanlimab
  • Drug: Cisplatin
    • COLLABORATORS
    N/A
    DATE
    Feb 2015 - Dec 2021
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    UNIVERSITY OF ALABAMA AT BIRMINGHAM COMPREHENSIVE CANCER CENTER
    BIRMINGHAM, AL, US, 35205
    Status
    Completed
    Location
    CEDARS-SINAI MEDICAL CENTER
    WEST HOLLYWOOD, CA, US, 90048
    Status
    Completed
    Location
    GEORGETOWN UNIVERSITY HOSPITAL
    WASHINGTON, DC, US, 20007
    Status
    Completed
    Location
    HEMATOLOGY ONCOLOGY ASSOCIATES OF THE TR
    PORT SAINT LUCIE, FL, US, 34952
    Status
    Completed
    Location
    UNIVERSITY OF MICHIGAN HEALTH SYSTEM
    ANN ARBOR, MI, US, 48109
    Status
    Completed
    Location
    WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
    SAINT LOUIS, MO, US, 63110
    Status
    Completed

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Male or female subjects, age 18 years or older on day of signing consent
    • 2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy

    Exclusion Criteria

    • 1. Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
    • 2. Prior receipt of a selective FGFR inhibitor

    Protocol Summary

    Incyte Study ID:
    INCB 54828-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    201
    Primary Outcome
    Open

    Determination of the maximum tolerated dose of Pemigatinib as a monotherapy and in combination as measured by the number of participants with adverse events

    Timeframe: from baseline through 21 days

    Assess the pharmacodynamics of pemigatinib as a monotherapy and in combination as indicated by serum phosphorus level

    Timeframe: up to 30 days (+ 5 days) follow-up visit

    Secondary Outcome
    Open

    Preliminary efficacy as assessed by Overall Response Rate (ORR) of Pemigatinib as monotherapy and in combination in subjects with measurable disease

    Timeframe: Day 15 of every third cycle (± 2 days) while subjects are on study

    Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy and in combination

    Timeframe: Cycle 1 Day 1, Day 2, Day 8 and Day 15

    Minimum observed plasma concentration (Cmin) during the dosing interval of Pemigatinib as monotherapy and in combination

    Timeframe: Cycle 1 Day 1, Day 2, Day 8 and Day 15

    Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy and in combination

    Timeframe: Cycle 1 Day 1, Day 2, Day 8 and Day 15

    Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy and in combination

    Timeframe: Cycle 1 Day 1, Day 2, Day 8 and Day 15

    Oral dose clearance (Cl/F) of Pemigatinib as monotherapy and in combination

    Timeframe: Cycle 1 Day 1, Day 2, Day 8 and Day 15