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Closed (no longer recruiting)Last updated: 23 January 2024

CT680: This phase I/II trial is evaluating an oral drug (TAS-120) in patients with an advanced solid cancer or Multiple MyelomaA Dose-Finding Phase 1 Study of TAS-120 in Patients With Advanced Solid Tumors With or Without Fibroblast Growth Factor/Receptor (FGF/FGFR)-Related Abnormalities Followed By A Phase 2 Study in Patients With Advanced Solid Tumors or Multiple Myeloma With FGF/FGFR-Related Abnormalities

Clinical summary

Summary

The purpose of this study is to determine the safety of TAS-120 and determine the most appropriate dose for the subsequent phase 2 safety and efficacy study in patients with advanced solid tumors and multiple myeloma with genetic abnormalities. The progression of cancers is caused by a complex series of multiple genetic and molecular events leading to changes in the patients DNA. The fibroblast growth factor/fibroblast growth factor receptor (FGF/FGFR) signaling pathway is important for normal organ, vascular and skeletal development. However, FGFR gene abnormalities have been linked to various cancers. TAS-120 is a highly potent, selective small molecule inhibitor of FGFR and is therefore is being studied as a therapy for cancer.

Conditions

This trial is treating patients with advanced solid cancers or Multiple Myeloma.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I/II

Trial Acronym

CT680

More information

Trial Identifiers

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Trial sponsor

Taiho Pharma USA, Inc.

Scientific Title

A Dose-Finding Phase 1 Study of TAS-120 in Patients With Advanced Solid Tumors With or Without Fibroblast Growth Factor/Receptor (FGF/FGFR)-Related Abnormalities Followed By A Phase 2 Study in Patients With Advanced Solid Tumors or Multiple Myeloma With FGF/FGFR-Related Abnormalities

Eligibility

Inclusion

  1. Provide written informed consent
  2. Age ≥ 18 years of age
  3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer
  4. The following specific criteria for each study portion

    Phase 1 (Dose Escalation):

    • Patients with any type of solid tumor
    • Disease progression following standard therapies or intolerant to prior standard therapies

    Phase 1 (Dose Expansion)

    • Have at least one FGF/FGFR aberration
    • Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
    • Have 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.
    • Patients with any of the following tumor types

      • Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
      • Patients with primary CNS tumors
      • Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
      • Patients with breast cancer or gastric cancer
      • Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
      • Patients with solid tumor types and other FGF/FGFR alterations not listed above

    Phase 2

    • Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
    • Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
    • Must have documentation of radiographic progression of disease
    • No prior FGFR inhibitor
    • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Adequate organ function.

Exclusion

  1. History and/or current evidence of clinically significant 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
  4. A serious illness or medical condition(s)
  5. Pregnant or breast-feeding female

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
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Clinical trials have complex eligibility criteria.

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