Last updated on July 2019

A Study of TAS-120 in Patients With Advanced Solid Tumors

Are you eligible to participate in this study?

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

  • Conditions: Activating Mutations | Solid Tumors | FGFR2 Amplification | Malignant neoplasm of brain | Other Tumor Types With FGFR2 Gene Fusions | Cholangiocarcinoma | Multiple Myeloma | Urothelial Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

Has histologically or cytologically confirmed, locally advanced, metastatic cancer meeting the following criteria:

Phase 1 Expansion

  1. Patient has failed all standard therapies or standard therapy does not exist or is not tolerated.
  2. Patient has specific FGF/FGFR aberrations
    • Intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR2 abnormalities, i.e., gene mutations (see Appendix A), rearrangements or amplifications
    • Glioblastoma or grade III glioma (i.e., anaplastic astrocytoma or anaplastic oligodendroglioma) with FGFR gene fusions or activating mutations.
    • Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
    • All other tumor types harboring FGF9, FGF19 or FGFR2 amplifications ( 10 copies), FGFR gene fusions, or FGFR activating mutations

Phase 2

  1. Patient has histologically or cytologically confirmed, locally advanced, metastatic, unresectable iCCA harboring FGFR2 gene fusions based on results from a NGS assay by the Sponsor's designated central laboratory
  2. Patient has been treated with and failed at least one prior systemic gemcitabine and platinum-based chemotherapy for the advanced disease
  3. Must have documentation of radiographic progression of disease on prior systemic therapy
  4. Patient has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO criteria (2010) for brain tumors.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Adequate organ function

Exclusion Criteria:

A patient will be excluded from this study if any of the following criteria are met:

  1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.
  2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
  3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
  4. A serious illness or medical condition(s)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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