Using TAS-117 to Treat Advanced Solid Tumors with Inherited PTEN Mutations
Breast, Colorectal, Endometrial
Study Contact Information:
For additional information, please contact:
Osamu Takahashi, MD, PhD by phone: 609-250-7336 or by email at: email@example.com
Treating Advanced Solid Tumors in People with Inherited PTEN Mutations Using the New Drug TAS-117
About the Study
This study will look at how well the targeted therapy TAS-117 works for treating people with an inherited PTEN mutation and advanced or metastatic solid tumors (excluding primary brain tumors).
Type of Study
This is an open-label, non-randomized study.
- In this open-label 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 toxicity, or a reason to discontinue treatment is met.
- Santa Monica, CA
Sarcoma Oncology Research Center
- New York, NY
Memorial Sloan Kettering Cancer Center
- Cleveland, OH
Cleveland Clinic Lerner Research Institute
- Philadelphia, PA
Children's Hospital of Philadelphia
- Houston, TX
The University of Texas M.D. Anderson Cancer Center
People may be eligible if they have the following:
- Advanced solid tumor.
- The disease has progressed after standard treatment for advanced or metastatic 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 PTEN mutation
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.