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PI3K Inhibitor

TAS-117 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with solid tumors irrespective of gene alterations.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights

Study Summary

This trial will test a new drug, TAS-117, on patients with cancer that has spread or come back and who have a specific genetic mutation. The goal is to see if the drug is safe and effective.

Eligible Conditions
  • Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating Mutations
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Patients with any type of solid tumor, regardless of specific gene changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events and dose-limiting toxicities (safety and tolerability) and MTD of TAS-117 in Part A
Objective Response Rate (ORR) in Part B (including all patients with germline PTEN mutations in Part A)
Recommended Phase 2 Dose (RP2D) of TAS-117 in Part A
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Therapeutic procedure
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: TAS-117 Phase 2 (Part B)Experimental Treatment1 Intervention
Advanced or metastatic solid tumors with germline PTEN inactivating mutations
Group II: TAS-117 Dose and Regimen Confirmation (Part A: safety lead-in)Experimental Treatment1 Intervention
Advanced or metastatic solid tumors with germline PTEN inactivating mutations
Group III: TAS-117 Dose Escalation Intermittent Dose Regimen (Part A: safety lead-in)Experimental Treatment1 Intervention
Advanced or metastatic solid tumors irrespective of gene alterations
Group IV: TAS-117 Dose Escalation Daily Dose Regimen (Part A: safety lead-in)Experimental Treatment1 Intervention
Advanced or metastatic solid tumors irrespective of gene alterations
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS-117
2017
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,546 Total Patients Enrolled

Media Library

TAS-117 (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04770246 — Phase 1
Solid Tumors Research Study Groups: TAS-117 Dose Escalation Daily Dose Regimen (Part A: safety lead-in), TAS-117 Phase 2 (Part B), TAS-117 Dose Escalation Intermittent Dose Regimen (Part A: safety lead-in), TAS-117 Dose and Regimen Confirmation (Part A: safety lead-in)
Solid Tumors Clinical Trial 2023: TAS-117 Highlights & Side Effects. Trial Name: NCT04770246 — Phase 1
TAS-117 (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770246 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many medical facilities is this research project being conducted right now?

"There are 10 potential sites for this trial, with 5 already confirmed. The University of Texas M.D. Anderson Cancer Center in Houston, Children's Hospital of Philadelphia in Philadelphia, and Sarcoma Oncology Research Center in Santa Monica have been confirmed as sites thus far with 5 other locations still being considered."

Answered by AI

Has this clinical trial been done before?

"As of right now, there is a single active clinical trial for TAS-117 being conducted in 7 metropolitan areas and 4 countries. The first ever TAS-117 drug trial was completed in 2021 by Taiho Oncology, Inc. That study had 96 total patients and finished Phase 2 of the approval process."

Answered by AI

What are researchers aiming to discover through this trial?

"The primary objective for this trial, as stated by the sponsor Taiho Oncology, Inc., is to assess the Objective Response Rate (ORR) over a period of 21 days for DLT evaluation and 7 months for all other patients. This study will also be evaluating secondary outcomes including the Pharmacodynamics (PD) profile of TAS-117 in Part A, Progression Free Survival (PFS), and Pharmacokinetics (PK) profile of TAS-117 in Part A."

Answered by AI

Are there other examples of TAS-117 being used in a medical setting?

"TAS-117 was first researched in 2021 at Centre Georges-Franois Leclerc. So far, 1 clinical trial has been completed while 1 additional study is ongoing. Most of the active research surrounding TAS-117 is taking place in Houston, Texas."

Answered by AI

Is it possible to join this research project at this time?

"Unfortunately, this particular clinical trial is not currently recruiting patients. Although, it was first posted on March 31st, 2021 and last updated on November 9th, 2022. There are other trials that may be of interest; 2462 for advanced or metastatic solid tumors with germline pten inactivating mutations and 1 TAS-117 study actively enrolling patients."

Answered by AI

How many volunteers are enrolled in this research project?

"This trial is no longer looking for participants. The study was originally posted on March 31st, 2021 and the last update was on November 9th, 2022. However, there are currently 2462 trials actively recruiting patients with advanced or metastatic solid tumors with germline pten inactivating mutations and 1 trial for TAS-117 that is also seeking patients."

Answered by AI

Could you please explain the risks associated with TAS-117?

"Given that TAS-117 is still in Phase 2 clinical trials, there is limited data on its efficacy. However, there are no safety concerns at this time, so it received a score of 2."

Answered by AI
~4 spots leftby Mar 2025