Trial ID or NCT#

NCT02448251

Status

NOT RECRUITING

Purpose

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.

Official Title

A Phase I, Multicenter, Open-Label Safety, Pharmacokinetic and Preliminary Efficacy Study of Wild-type Sparing EGFR Inhibitor, AC0010MA, in Adult Patients With Previously Treated EGFRmut and Acquired T790M Mutation Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Heather Wakelee, MD
Medical oncologist, Thoracic specialist
Professor of Medicine (Oncology) at the Stanford University Medical Center
Kavitha Ramchandran
Medical oncologist, Palliative medicine doctor, Thoracic specialist, Internal medicine doctor
Clinical Associate Professor, Medicine - Oncology
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Assistant Professor of Medicine (Oncology) at the Stanford University Medical Center
Millie Das, MD
Medical oncologist, Thoracic specialist
Clinical Assistant Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

CONTACT

Lisa Zhou
(650) 736-4112