Clinical Trials /

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

NCT03017521

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
TAS-117TAS-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

NameTypeDescriptionInterventions
TAS-117ExperimentalTAS-117, 16mg, orally, daily
  • TAS-117

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:Recruiting
Lead Sponsor:Yonsei University

Trial Keywords

  • Refractory solid tumors
  • AKT inhibitor

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