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TAS-117 for Solid Tumors
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.
- 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 belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Patients with any type of solid tumor, regardless of specific gene changes.
- Group 1: TAS-117 Dose Escalation Daily Dose Regimen (Part A: safety lead-in)
- Group 2: TAS-117 Phase 2 (Part B)
- Group 3: TAS-117 Dose Escalation Intermittent Dose Regimen (Part A: safety lead-in)
- Group 4: TAS-117 Dose and Regimen Confirmation (Part A: safety lead-in)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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