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

• ClinicalTrials.gov Identifier: NCT03017521
• Recruitment Status: Completed
• First Posted: January 11, 2017
• Last Update Posted: July 1, 2020
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Minkyu Jung, Yonsei University

Tracking Information

• First Submitted Date: January 9, 2017
• First Posted Date: January 11, 2017
• Last Update Posted Date: July 1, 2020
• Actual Study Start Date: November 21, 2017
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 10, 2017): overall response rate [ Time Frame: 2 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor, Adult

Intervention

Drug: TAS-117

TAS-117 16mg, daily

Study Arms

Experimental: TAS-117

TAS-117, 16mg, orally, daily

Intervention: Drug: TAS-117

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 30, 2020): 13
• Original Estimated Enrollment (submitted: January 10, 2017): 30
• Actual Study Completion Date: December 31, 2019
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03017521
• Other Study ID Numbers: 4-2016-0743
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Minkyu Jung, Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: June 2020