NCT03017521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

January 9, 2017

Last Update Submit

April 21, 2021

Conditions

Solid Tumor, Adult

Keywords

Refractory solid tumorsAKT inhibitor

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    2 months

Study Arms (1)

TAS-117

EXPERIMENTAL

TAS-117, 16mg, orally, daily

Drug: TAS-117

Interventions

TAS-117DRUG

TAS-117 16mg, daily

TAS-117

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33723724DERIVED

MeSH Terms

Interventions

3-amino-1-methyl-3-(4-(3-phenyl-5H- imidazo(1,2-c)pyrido(3,4-e)(1,3)oxazin-2-yl)phenyl)cyclobutanol

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 11, 2017

Study Start

November 21, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations

KR(1)