A phase 2 study of TAS-117 in patients with PTEN gene mutations cancer
Research type
Research Study
Full title
A Phase 2 Study of TAS-117 in Patients with Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations.
IRAS ID
296966
Contact name
Elisa Fontana
Contact email
Sponsor organisation
Taiho Oncology Inc.
Eudract number
2020-004770-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is a clinical research trial of TAS-117 (trial drug) which is a drug under investigation. TAS-117 is an oral research drug that blocks kinases (enzymes that catalyze reactions) named AKT1, 2, and 3. The AKT kinases are part of a cell that helps it grow and PTEN gene regulates AKT in the same signal pathway. Germline mutation is a gene change in a body’s reproductive cell (egg or sperm) and are passed on from parents to offspring. Some cancers may grow if AKT or PTEN are not acting normally. TAS-117 may be able to stop cancer growth by blocking AKT, 1, 2, and 3. The main purpose of the trial is to find the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), and to study the efficacy of TAS-117 in participants who have advanced cancer (excluding brain cancer) with or without germline PTEN mutations. The MTD is the highest and safest dose to give participants. The RP2D is the dose that will be used in participants that is the safest and has the best chance at shrinking cancer tumours. Efficacy is studying if TAS-117 can stop or shrink the tumour. Another purpose of this trial is to understand the pharmacokinetics and pharmacodynamics of TAS-117. Pharmacokinetics allows us to examine how the body processes a drug (i.e., what the body does to the drug) and pharmacodynamics allows us to find out how the body reacts to a drug (i.e., what the drug does to the body).
There are two parts in this trial. Part A of the trial is studying different doses and regimens of the study drug in order to understand side effects and safety of TAS-117 in participants who have any advanced cancer (excluding brain cancer) with or without germline PTEN mutation. Part B is studying one dose and regimen of TAS-117 in participants who have any advanced cancer (excluding brain cancer) with germline PTEN mutations. In Part A of the trial, about 42 participants will be enrolled in the trial at about 6-10 hospitals. In Part B of the trial, about 60 participants will be enrolled in the trial at about 80 hospitals around the world. About 100 participants will be enrolled in the whole trial. Open-label trial: Both the participant and the study doctor will know what trial drug participants are receiving.
As requested by FDA, adolescent patients (≥12 and <18 years of age) may be enrolled in the Dose and Regimen Confirmation (Part A) and Phase 2 (Part B) portions of the study.REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0273
Date of REC Opinion
14 Jun 2021
REC opinion
Further Information Favourable Opinion