K-BASKET, TAS-117, PI3K/AKT Gene Aberration

Study Overview
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Brief Summary
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The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.

Official Title
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A Phase II Study of TAS-117 in Advanced Solid Tumors With PI3K/AKT Gene Aberration (Part of K-BASKET Trial; Korea-Biomarker-driven Multi-arm Drug-screening, Knowledge and Evidence-generating Targeted Trial)

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Drug: TAS-117


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration Progressive disease who failed to previous standard treatment. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria Eastern Cooperative Oncology Group performance status 0 or 1 Able to take medications orally Adequate organ function A life expectancy of at least 60 days Exclusion Criteria: Previous treatment with anti-PI3K or AKT directed therapies Known hypersensitivity to any drugs similar to TAS-117 in structure or class. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy. Current evidence of retinopathy that requires ophthalmological therapy. History or current evidence of cardiac arrhythmia and/or conduction abnormality. Treatment with any of the following within the specified time frame prior to study drug administration: Major surgery within prior 4 weeks Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration. Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks). A serious illness or medical condition(s) Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia). Patients with the risk of hypokalemia Receiving oral steroid medication. Pregnant or lactating female

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-117<br>TAS-117, 16mg, orally, daily | Drug: TAS-117<br>* TAS-117 16mg, daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory solid tumors, AKT inhibitor