Status:
TERMINATED
TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations
Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating Mutations
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding...
Detailed Description
Study TAS-117-201 is an open-label, single-arm Phase 2 study evaluating the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of TAS-117 in patients with advanced or metastatic so...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Dose Escalation in Part A
- ≥18 years of age.
- Histologically or cytologically confirmed advanced or metastatic solid tumors
- Has progressed after standard treatment for advanced or metastatic disease or was intolerant to or ineligible for available standard therapies.
- Patients with solid tumors irrespective of gene alterations.
- Patients with at least one measurable or non-measurable lesion per RECIST1.1
- Dose and Regimen Confirmation in Part A and Phase 2 (Part B)
- ≥12 years of age. Patients age ≥12 and \<18 years must have a body weight of ≥40 kg.
- Histologically confirmed advanced or metastatic solid tumors.
- Has progressed after standard treatment for advanced or metastatic disease or was intolerant or ineligible to available standard therapies.
- Patients with locally confirmed germline PTEN inactivating mutations determined from a blood sample.
- Patients with at least one measurable lesion per RECIST 1.1.
- Exclusion Criteria
- History or current evidence of interstitial lung disease that requires steroid medication.
- Current evidence of diabetes mellitus that requires insulin therapy.
- Prior treatment with PI3K/AKT/mTOR pathway inhibitors.
- Patients with primary brain tumor.
- Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastasis.
- Currently receiving chronic corticosteroid therapy of ≥10 mg/day of prednisone or its equivalent.
Exclusion
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04770246
Start Date
March 31 2021
End Date
March 6 2023
Last Update
September 4 2024
Active Locations (8)
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1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Cleveland Clinic Lerner Research Institute
Cleveland, Ohio, United States, 44195
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104