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NCT02448251 · ClinicalTrials.gov registry record · Phase 1

Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer

A Phase 1 study, sponsored by ACEA Therapeutics.

Terminated
Registry status
Phase 1
Development phase
28
Enrollment target

NCT02448251 is a Phase 1 study that was terminated before completion, run by ACEA Therapeutics. The registered enrollment target is 28 participants.

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The verdict

NCT02448251, a Phase 1 study, was terminated before completion, sponsored by ACEA Therapeutics.

TERMINATED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1. Irreversible binding to EGFR; 2. Effectively suppresses the tumor cell with EGFR mutant while has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR T790M drug-resistant mutation.

Interventions

  • DRUG AC0010MA

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2015-05
Est. Completion 2019-10
Phase Phase 1

Sponsor

ACEA Therapeutics

2 total trials

What the Registry Record Tells You About NCT02448251

The ClinicalTrials.gov registry entry for NCT02448251 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ACEA Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AC0010MA is the first listed.

NCT02448251 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02448251 about?

NCT02448251 is a clinical study titled "Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer". AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the E...

What is the current status of trial NCT02448251?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-05. Estimated completion is 2019-10.

What interventions are being tested in trial NCT02448251?

The interventions under investigation include: AC0010MA (DRUG).

Who is sponsoring clinical trial NCT02448251?

This trial is sponsored by ACEA Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.