Last updated on January 2020

Phase I Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: All Solid Tumors | Cancer (Pediatric) | Transitional cell carcinoma | Urothelial Carcinoma | Neoplasms | Non-Small Cell Lung Cancer | Bladder Carcinoma | bladder cancer | Ewing's Family Tumors | Urothelial Cancer | Cancer/Tumors | Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    For dose escalation: Subjects with any type of solid tumor (all comer) will be
    eligible for dose escalation and dose expansion at MTD in Part 1; Subjects enrolled
    for dose expansion (MTD expansion cohort "all comer") will be stratified according to
    high fibroblast growth factor receptor (FGFR) expression levels / FGFR mutation using
    archival or fresh tumor biopsy material
    For expansion cohorts: Subjects will be eligible for Part 2 only if they have
    histological or cytological confirmed squamous non-small cell lung cancer (sqNSCLC),
    lung adenocarcinoma, head and neck cancer or bladder cancer (BC). All subjects in Part
    2 will be stratified according to high FGFR expression levels FGFR mutation using
    archival or fresh tumor biopsy specimen. BC subjects with low overall FGFR expression
    levels can be included if activating FGFR3(FGFR tyrosine kinases3) mutations are
    Subjects must have measurable disease (Response evaluation criteria in solid tumors
    (RECIST 1.1))
    Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
    Bone marrow, liver and renal functions as assessed by adequate laboratory methods to
    be conducted within 7 days prior to starting study Treatment
    Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 according to the modified diet in
    renal disease (MDRD) abbreviated formula

You may not be eligible for this study if the following are true:

  • Previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase
    inhibitors or FGFR-specific antibodies)
    Concomitant therapies that cannot be discontinued or switched to a different
    medication prior to study entry that are known to increase serum phosphate levels are
    not permitted within 4 weeks prior to start of study treatment)
    Anticancer chemotherapy or immunotherapy during the study or within 5-halflives prior
    to start of study treatment. Mitomycin C, nitrosoureas or monoclonal antibodies with
    anticancer activity (e.g. bevacizumab or cetuximab etc.) should not be given within 6
    weeks before starting to receive study treatment or within 6 weeks of pre-treatment
    biopsy for biomarker (p-ERK1/2) studies

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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