Spots Global Cancer Trial Database for Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer
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Trial Identification
Brief Title: Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer
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)
Study ID: NCT02448251
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Stanford University, Palo Alto, California, United States
Emory University School of Medicine, Atlanta, Georgia, United States
MD Anderson Cancer Center, Houston, Texas, United States
CEPCM - Hopital Timone, Marseille, , France
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
START-Madrid-FJD, Madrid, , Spain
START-Madrid-CIOCC, Madrid, , Spain
Contact Details
Name: Vali A. Papadimitrakopoulou, MD
Affiliation: MD Anderson Cancer Center, Houston, TX, USA
Role: STUDY_DIRECTOR
Name: Suresh S. Ramalingam, MD
Affiliation: Emory University School of Medicine, Atlanta, GA, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Heather Wakelee, MD
Affiliation: Stanford University, Palo Alto, CA, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Karen L Reckamp, MD
Affiliation: City of Hope Comprehensive Cancer Center, Duarte, CA, USA
Role: PRINCIPAL_INVESTIGATOR
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