Clinical Trials Using pan FGFR Kinase Inhibitor BGJ398

Clinical trials are research studies that involve people. The clinical trials on this list are studying pan FGFR Kinase Inhibitor BGJ398. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-6 of 6
  • Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

    This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and / or nephrectomy. Study treatment is randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence.
    Location: 22 locations

  • Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions / Translocations

    Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions / translocations. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.
    Location: 16 locations

  • A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

    This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.
    Location: 8 locations

  • Infigratinib in Combination with Tamoxifen for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic or Locally Recurrent Unresectable Breast Cancer

    This phase IB trial evaluates the best dose of infigratinib when given in combination with tamoxifen in treating patients with hormone receptor-positive, HER2-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and cannot be removed by surgery (unresectable). Infigratinib, a drug that targets the FGFR cancer pathway, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Tamoxifen blocks the use of estrogen by tumor cells. Researchers hope to learn if infigratinib, a drug that targets the FGFR cancer pathway, can be safely added to current anti-hormonal therapies, specifically those including tamoxifen (Nolvadex or Soltamox).
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients with FGFR Gene Mutations

    This phase II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body (advanced or metastatic) in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations. Mutations are any changes in the genetic material (DNA) of a cell. FGFR proteins are involved in cell division, cell maturation, formation of new blood vessels, wound healing, and bone growth, development, and maintenance. FGFR mutations can cause the FGFR protein to become over-active in diseases such as cancer. Infigratinib may stop the growth of tumor cells by blocking FGFR proteins in these tumors.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Infigratinib before Surgery for the Treatment of Upper Tract Urothelial Cancer

    This phase Ib trial studies the side effects of infigratinib before surgery in treating patients with upper tract urothelial cancer. Infigratinib may stop the growth of tumor cells by blocking the activities of a gene called FGFR needed for cell growth. Giving infigratinib before surgery may cause the tumor to shrink, which may make the surgical procedure easier and / or reduce the need for more extensive surgery.
    Location: M D Anderson Cancer Center, Houston, Texas