Description:
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.
Title
- Brief Title: K-BASKET, TAS-117, PI3K/AKT Gene Aberration
- 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)
Clinical Trial IDs
- ORG STUDY ID:
4-2016-0743
- NCT ID:
NCT03017521
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TAS-117 | | TAS-117 |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
TAS-117 | Experimental | TAS-117, 16mg, orally, daily | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | overall response rate |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Yonsei University |
Trial Keywords
- Refractory solid tumors
- AKT inhibitor
Last Updated
April 22, 2021