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

NCT02448251 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-10-29

No results posted yet for this 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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

AC0010MA

Following Phase I, a protocol amendment will be submitted to the IND to specify the selected dose and dose justification to be used in Phase II.

Sponsors & Collaborators

  • ACEA Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Vali A. Papadimitrakopoulou, MD · MD Anderson Cancer Center, Houston, TX, USA

  • Suresh S. Ramalingam, MD · Emory University School of Medicine, Atlanta, GA, USA

  • Heather Wakelee, MD · Stanford University, Palo Alto, CA, USA

  • Karen L Reckamp, MD · City of Hope Comprehensive Cancer Center, Duarte, CA, USA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • United States
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02448251 on ClinicalTrials.gov