TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations (NCT04770246) | Clinical Trial Compass
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 States, Austria, France17 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 range
12 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Recommended Phase 2 Dose (RP2D) of TAS-117 in Part A
Timeframe: 21 days for DLT evaluation, approximately 7 months for the others
3
Objective Response Rate (ORR) in Part B (including all patients with germline PTEN mutations in Part A)