K-BASKET, TAS-117, PI3K/AKT Gene Aberration | NCT03017521

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

NCT03017521

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Apr 22, 2021Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Solid Tumor, Adult

Interventions

TAS-117

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jan 9, 2017

First Submission Date that Met QC Criteria

Jan 10, 2017

First Posted Date

Jan 11, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2021

Last Update Posted Date

Apr 22, 2021Actual

Description Module

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.

Detailed Description

Not provided

Label	Type	Description	Intervention Names
TAS-117	Experimental	TAS-117, 16mg, orally, daily	Drug: TAS-117

Name	Type	Description	Arm Group Labels	Other Names
TAS-117	Drug	TAS-117 16mg, daily	TAS-117

Measure	Description	Time Frame
overall response rate		2 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital, Yonsei University Health System		Seoul		03722	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33723724	Derived	Lee JB, Jung M, Beom SH, Kim GM, Kim HR, Choi HJ, Sohn JH, Ahn JB, Rha SY, Chung HC. Phase 2 study of TAS-117, an allosteric akt inhibitor in advanced solid tumors harboring phosphatidylinositol 3-kinase/v-akt murine thymoma viral oncogene homolog gene mutations. Invest New Drugs. 2021 Oct;39(5):1366-1374. doi: 10.1007/s10637-021-01085-7. Epub 2021 Mar 15.