A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors or Multiple Myeloma With FGF/FGFR-Related Abnormalities

Overview

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.
SparkCures ID 403
Trial Phase Phase 1/2
Enrollment 835 Patients
Treatments
  • TAS-120
Trial Sponsors
  • Taiho Oncology, Inc.
NCT Identifier

NCT02052778

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Provide written informed consent.
  • Is ≥18 years of age.
  • Patients with confirmed advanced metastatic solid tumor(s) with or without abnormalities of FGF/FGFR who have failed all standard therapies or for whom standard therapy does not exist.
  • Patients with confirmed multiple myeloma with amplification, mutation or translocation or other associated abnormalities of FGF/FGFR who have failed all standard therapies or for whom standard therapy does not exist.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Women of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

  • History of endocrine alteration of calcium-phosphorus homeostasis.
  • History of ectopic mineralization/calcification
  • Current evidence of corneal disorder/keratopathy
  • History or current evidence of cardiac arrhythmia and/or conduction abnormality.
  • QTc > 470 msec on ECG conducted during Screening period
  • Treatment with any of the following within the specified time frame prior to the first dose of TAS-120:
    • Major surgery within the previous 4 weeks
    • Radiotherapy for extended field within 4 weeks
    • Any noninvestigational anticancer therapy within 3 weeks
    • Any medication administered within 7 days prior to first dose of TAS-120 that is known to affect QT interval
    • Any investigational agent received either concurrently or within the previous 30 days.
  • A serious illness or medical condition(s)
  • Known hypersensitivity to TAS-120 or any drugs similar to it in structure or class.
  • Pregnant or lactating female.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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