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Treating Advanced Solid Tumors in People with Inherited PTEN Mutations Using the Investigational Drug TAS-117

Treating Advanced Solid Tumors in People with Inherited PTEN Mutations Using the Investigational Drug TAS-117

Clinicaltrials.gov identifier:
NCT04770246

Treatment
People with advanced cancer and an inherited PTEN mutation

Study Contact Information:

For additional information, please contact:

Osamu Takahashi, MD, PhD by phone: 609-250-7336 or by email at: clinicaltrialinfo@taihooncology.com


Treating Advanced Solid Tumors in People with Inherited PTEN Mutations Using the Investigational Drug TAS-117

About the Study

This study will look at how well the TAS-117 works for treating people with an inherited mutation and advanced or solid tumors (excluding primary brain tumors).

Type of Study

This is an , study.

  • In this  study, all participants will receive the same medication.

What the Study Entails

All participants will receive TAS-117 orally every day or intermittently on a 21-day cycle.

Participants will be followed every 12 weeks for approximately 1 year, until disease progression, unacceptable , or a reason to discontinue treatment is met.

Study Sites

California

  • Santa Monica, CA
    Sarcoma Oncology Research Center                   

New York

  • New York, NY
    Memorial Sloan Kettering Cancer Center    

Ohio

  • Cleveland, OH
    Cleveland Clinic Lerner Research Institute          

Pennsylvania

  • Philadelphia, PA
    Children's Hospital of Philadelphia  

Texas

  • Houston, TX
    The University of Texas M.D. Anderson Cancer Center        
This Study is Open To:

People may be eligible if they have the following:

  • Advanced solid tumor.
  • The disease has progressed after standard treatment for advanced or cancer or they couldn't tolerate or are ineligible for available standard therapies.
  • Age 12 or older (for patients between the ages of 12 and 18 they must have a body weight of at least 88 lbs).
  • Tested positive for an inherited mutation
This Study is Not Open To:

People cannot participate if they:

  • Have interstitial lung disease requiring steroid medication.
  • Are diabetic requiring insulin therapy.
  • Have had prior treatment with PI3K/AKT/mTOR pathway inhibitors.
  • Have a primary brain tumor.
  • Are receiving ≥10 mg/day of prednisone or its equivalent.