- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017521
K-BASKET, TAS-117, PI3K/AKT Gene Aberration
April 21, 2021 updated by: Minkyu Jung, Yonsei University
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)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAS-117
TAS-117, 16mg, orally, daily
|
TAS-117 16mg, daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2017
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
January 10, 2017
First Posted (Estimate)
January 11, 2017
Study Record Updates
Last Update Posted (Actual)
April 22, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4-2016-0743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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