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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03017521

Enrollment

Registered

2017-01-11

Start date

2017-11-21

Completion date

2019-12-31

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Adult

Keywords

Refractory solid tumors, AKT inhibitor

Brief summary

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.

Interventions

DRUGTAS-117

TAS-117 16mg, daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration 2. Progressive disease who failed to previous standard treatment. 3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. Able to take medications orally 6. Adequate organ function 7. A life expectancy of at least 60 days

Exclusion criteria

1. Previous treatment with anti-PI3K or AKT directed therapies 2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class. 3. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy. 4. Current evidence of retinopathy that requires ophthalmological therapy. 5. History or current evidence of cardiac arrhythmia and/or conduction abnormality. 6. 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). 7. A serious illness or medical condition(s) 8. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia). 9. Patients with the risk of hypokalemia 10. Receiving oral steroid medication. 11. Pregnant or lactating female

Design outcomes

Primary

Measure	Time frame
overall response rate	2 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026