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NCT03975387 · ClinicalTrials.gov registry record · Phase 1

Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53

A Phase 1 study, sponsored by Taiho Oncology.

Terminated
Registry status
Phase 1
Development phase
106
Enrollment target

NCT03975387: Clinical Trial Phase 1 study, sponsored by Taiho Oncology.

NCT03975387 is a Phase 1 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03975387, a Phase 1 study, was terminated before completion, sponsored by Taiho Oncology.

TERMINATED
Registry status
Phase 1
Development phase
106 participants
Enrollment target

Study Summary

Study ASTX295-01 is a first in human Phase 1/2 open-label study of the safety, pharmacokinetics, and preliminary activity of ASTX295 in participants with wild-type TP53 advanced solid tumors. Phase 1 is a dose escalation and dose expansion study design. Sponsor made the strategic decision to not pursue the Phase 2 part of the study.

Interventions

  • DRUG ASTX295

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2019-07-11
Est. Completion 2024-08-15
Phase Phase 1
Taiho Oncology

52 total trials

Why NCT03975387 stopped before completion

NCT03975387 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).

The record links to 0 conditions, and to 1 intervention - of which ASTX295 is the first listed.

NCT03975387 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03975387 about?

NCT03975387 is a clinical study titled "Study of ASTX295 in Patients With Solid Tumors With Wild-Type p53". Study ASTX295-01 is a first in human Phase 1/2 open-label study of the safety, pharmacokinetics, and preliminary activity of ASTX295 in participants with wild-type TP53 advanced solid tumors. Phase 1 is a dose escalation and dose expansion study design. Sponsor made the strategic decision to not pur...

What is the current status of trial NCT03975387?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2019-07-11. Estimated completion is 2024-08-15.

What interventions are being tested in trial NCT03975387?

The interventions under investigation include: ASTX295 (DRUG).

Who is sponsoring clinical trial NCT03975387?

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 NCT03975387's enrollment target sits among peer trials

106 531st of 2000 higher than 1,468 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 NCT03975387, the US trial registry maintained by the National Library of Medicine. NCT03975387 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.