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

NCT04770246 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-09-04

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations
  • Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating Mutations

Interventions

DRUG

TAS-117

TAS-117 will be dosed orally every day on a 21-day cycle

DRUG

TAS-117

TAS-117 will be dosed intermittently on a 21-day cycle

DRUG

TAS-117

TAS-117 will be dosed orally every day or intermittently on a 21-day cycle

DRUG

TAS-117

TAS-117 will be dosed orally every day or intermittently on a 21-day cycle

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-02-28
Completion
2023-03-06
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770246 on ClinicalTrials.gov