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Protocol No. UW16091

Principal Investigator Lubner, Sam

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 2, Open-label, Single -Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

Objective The purpose of this research study is to assess how advanced/metastatic or surgically unresectable Cholangiocarcinoma with or without FGF/FGFR alterations responds to treatment with INCB054828, a selective FGFR inhibitor. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, to study the way in which the study drug is broken down in the body and eliminated, and to obtain data to try and identify patients who would benefit most from the study drug.

Treatment INCB054828 (study drug) is an oral medicine (taken by mouth) which has not been approved by U.S. Food and Drug Administration (FDA) for the treatment of people with your medical condition. The medicine being tested in this study is currently not "on the market" (available to be prescribed or buy) and is considered to be investigational.

Description Subjects will be enrolled into 1 of 3 cohorts. A subject's cohort will be determined by FGF/FGFR gene alteration status. Cohort A: FGFR2 translocation, Cohort B: other FGF/FGFR alterations and Cohort C: negative for FGF/FGFR alteration. The treatment regimen is INCB054828 once a day by mouth for 2 consecutive weeks and 1 week off-therapy for every 3 weeks or 21-day cycle. The cycles will continue as long as you and your doctor feel that you are continuing to receive benefit from treatment. The estimated time you might be in the study is about 24 months. However, the exact length of time you will be in the study depends on how you respond to treatment. The Study Doctor may discontinue study treatment at any time if it is determined your disease has progressed, you experience intolerable or unacceptable side effects, your doctor determines that your safety is at risk, you become pregnant, you have a complete response to the study medication, or the study ends. While on this study, you will be asked to complete questionnaires called "quality of life" questionnaires. These are made up of questions that will ask you how you are feeling and how your cancer is affecting your life both physically and emotionally.

Key Eligibility
  • Men and women, aged 18 or older
  • Histologically or cytologically confirmed cholangiocarcinoma
  • Tumor assessment for FGF/FGFR gene alteration status completed through the central laboratory
  • Documented disease progression after at least 1 line of prior systemic therapy
  • Patients are ineligible if they have prior receipt of selective FGFR inhibitor
  • Patients are ineligible if they received treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 28 days before first dose of study drug
  • Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases). Subjects with previously treated and clinically stable brain/CNS metastases and who are off all corticosteroids for greater than 4 weeks are eligible
  • Patients are ineligible if they have a known additional malignancy that is progressing or requires active treatment
  • Women who are pregnant or lactating are ineligible
  • Patients with a known history of human immunodeficiency virus (HIV) infection, evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are ineligible
  • Patients with concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization) are ineligible
  • Subjects with history of hypovitaminosis D requiring supraphysiologic doses to replenish the deficiency are ineligible. Subjects receiving vitamin D food supplements are allowed
  • Subjects with current evidence of clinically significant corneal or retinal disorder confirmed by opthalmologic examination are ineligible

Applicable Disease Sites Gastrointestinal cancers, other

Therapies Involved Other

Drugs Involved INCB054828

Status Open

Participating Institutions UW Hospital and Clinics