Solid Tumor, AdultPhase 2NCT03017521
K-BASKET, TAS-117, PI3K/AKT Gene Aberration
A Phase 2 study testing TAS-117 in people with Solid Tumor, Adult, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- TAS-117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2017to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul, 03722
About this study
Official title: 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.
- Conditions
- Solid Tumor, Adult
- Being tested
- TAS-117
- Keywords
- Refractory solid tumors, AKT inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-117Drug
TAS-117 16mg, daily
| Study group | Role | What they receive |
|---|---|---|
| TAS-117 | Experimental | TAS-117, 16mg, orally, daily Receives: Drug: TAS-117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start21 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minkyu Jung, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017521
- Sponsor's protocol ID
- 4-2016-0743
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2017
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33723724
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03017521
- Acronym / sponsor ID
- 4-2016-0743
- Conditions
- Solid Tumor, Adult
- Keywords
- Refractory solid tumors, AKT inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-117 | Experimental | Drug: TAS-117TAS-117, 16mg, orally, daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-117TAS-117 16mg, daily | Drug | TAS-117 |
Primary outcome
overall response rate
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 33723724Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-117 in people with Solid Tumor, Adult, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.