HM61713

DRUG4 trials

Sponsors

Hanmi Pharmaceutical Company Limited

Conditions

Healthy VolunteersNon Small Cell Lung Cancer

Phase 1

Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients

CompletedNCT01588145

Hanmi Pharmaceutical Company LimitedNon Small Cell Lung Cancer

Start: 2012-03-31End: 2017-08-31Updated: 2018-04-24

Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

CompletedNCT01894399

Hanmi Pharmaceutical Company LimitedHealthy Volunteers

Start: 2013-09-30End: 2013-11-30Updated: 2016-12-15

Phase 2

Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy

CompletedNCT02444819

Hanmi Pharmaceutical Company LimitedNon Small Cell Lung Cancer

Start: 2015-03-31End: 2017-08-31Updated: 2018-04-24

Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

TerminatedNCT02485652

Hanmi Pharmaceutical Company LimitedNon Small Cell Lung Cancer

Start: 2015-08-31End: 2020-12-08Updated: 2021-01-22

Related Papers

Abstract CT079: ELUXA 1: Ph II study of BI1482694 (HM61713) in patients (pts) with T790M-positive non-small cell lung (NSCLC) after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI)

Cancer Research2016-07-151 citations

BI 1482694 (HM61713), an EGFR mutant-specific inhibitor, in T790M+ NSCLC: Efficacy and safety at the RP2D.

Journal of Clinical Oncology2016-05-2041 citations

Abstract LB-256: Optimal clinical dose-finding strategies: Translational preclinical pharmacokineitcs, pharmacodynamics, and efficacy analysis of HM61713, an orally selective EGFR mutant inhibitor

Cancer Research2015-08-013 citations

Updated safety and efficacy results from phase I/II study of HM61713 in patients (pts) with EGFR mutation positive non-small cell lung cancer (NSCLC) who failed previous EGFR-tyrosine kinase inhibitor (TKI).

Journal of Clinical Oncology2015-05-2050 citations

Abstract LB-100: Discovery of HM61713 as an orally available and mutant EGFR selective inhibitor

Cancer Research2014-10-0141 citations

How I Treat Patients with Lung Cancer Harboring EGFR T790M

Oncology Times2014-07-31

Clinical activity and safety of HM61713, an EGFR-mutant selective inhibitor, in advanced non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations who had received EGFR tyrosine kinase inhibitors (TKIs).

Journal of Clinical Oncology2014-05-2070 citations