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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: Clinical Trial Phase 1 study, sponsored by ACEA Therapeutics.
NCT02448251 is a Phase 1 study that was terminated before completion, run by ACEA Therapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the safety and tolerability and to establish the maximum tolerated dose (MTD) of AC0010MA by incidence of dose limiting toxicity (DLT), defined as Grade 3 or 4 adverse events (AEs) and clinical lab abnormalities occurring within the first 28 days of treatment.
Interventions
- DRUG AC0010MA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-05 |
| Est. Completion | 2019-10 |
| Phase | Phase 1 |
Why NCT02448251 stopped before completion
NCT02448251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which AC0010MA is the first listed.
NCT02448251 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02448251's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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