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NCT04770246 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Taiho Oncology.

Terminated
Registry status
Phase 1
Development phase
17
Enrollment target

NCT04770246: Clinical Trial Phase 1 study, sponsored by Taiho Oncology.

NCT04770246 is a Phase 1 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04770246, a Phase 1 study, was terminated before completion, sponsored by Taiho Oncology.

TERMINATED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

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.

Primary Outcome

Number of patients with abnormal laboratory values, treatment emergent AEs, abnormal vital signs and ECG, and Dose-limiting toxicities (DLTs)

Interventions

  • DRUG TAS-117

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-03-31
Est. Completion 2023-03-06
Phase Phase 1
Taiho Oncology

52 total trials

Why NCT04770246 stopped before completion

NCT04770246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 1 intervention - of which TAS-117 is the first listed.

NCT04770246 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04770246 about?

NCT04770246 is a clinical study titled "TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations". 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.

What is the current status of trial NCT04770246?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-03-31. Estimated completion is 2023-03-06.

What interventions are being tested in trial NCT04770246?

The interventions under investigation include: TAS-117 (DRUG).

Who is sponsoring clinical trial NCT04770246?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04770246's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04770246, the US trial registry maintained by the National Library of Medicine. NCT04770246 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.