TerminatedPhase 1

TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations

Stopped: The Sponsor had decided to terminate this clinical trial due to an insufficient rate of accrual of patients.

United States17 participantsStarted 2021-03-31

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
✓. Dose Escalation in Part A
✓. ≥18 years of age.
✓. Histologically or cytologically confirmed advanced or metastatic solid tumors
✓. Has progressed after standard treatment for advanced or metastatic disease or was intolerant to or ineligible for available standard therapies.
✓. Patients with solid tumors irrespective of gene alterations.
✓. Patients with at least one measurable or non-measurable lesion per RECIST1.1
✓. Dose and Regimen Confirmation in Part A and Phase 2 (Part B)

Exclusion criteria

✕. History or current evidence of interstitial lung disease that requires steroid medication.
✕. Current evidence of diabetes mellitus that requires insulin therapy.

What they're measuring

Incidence of treatment-emergent adverse events and dose-limiting toxicities (safety and tolerability) and MTD of TAS-117 in Part A

Timeframe: 21 days for DLT evaluation, approximately 7 months for the others

Recommended Phase 2 Dose (RP2D) of TAS-117 in Part A

Timeframe: 21 days for DLT evaluation, approximately 7 months for the others

Objective Response Rate (ORR) in Part B (including all patients with germline PTEN mutations in Part A)

Timeframe: Approximately 6 months

Trial details

NCT IDNCT04770246

SponsorTaiho Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations trials

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
✓. Dose Escalation in Part A
✓. ≥18 years of age.
✓. Histologically or cytologically confirmed advanced or metastatic solid tumors
✓. Has progressed after standard treatment for advanced or metastatic disease or was intolerant to or ineligible for available standard therapies.
✓. Patients with solid tumors irrespective of gene alterations.
✓. Patients with at least one measurable or non-measurable lesion per RECIST1.1
✓. Dose and Regimen Confirmation in Part A and Phase 2 (Part B)

Exclusion criteria

✕. History or current evidence of interstitial lung disease that requires steroid medication.
✕. Current evidence of diabetes mellitus that requires insulin therapy.

What they're measuring

Incidence of treatment-emergent adverse events and dose-limiting toxicities (safety and tolerability) and MTD of TAS-117 in Part A

Timeframe: 21 days for DLT evaluation, approximately 7 months for the others

Recommended Phase 2 Dose (RP2D) of TAS-117 in Part A

Timeframe: 21 days for DLT evaluation, approximately 7 months for the others

Objective Response Rate (ORR) in Part B (including all patients with germline PTEN mutations in Part A)

Timeframe: Approximately 6 months