Spots Global Cancer Trial Database for Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients
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Trial Identification
Brief Title: Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients
Official Title: Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HM61713 in NSCLC Patients With EGFR Mutation
Study ID: NCT01588145
Conditions
Interventions
Study Description
Brief Summary: The main objective of this study is to evaluate the safety and tolerability of HM61713.
Detailed Description: Besides the main objective, there are 3 other objectives as follows: * To evaluate the anti-cancer effect of HM61713 in NSCLC patients with EGFR mutation * To investigate the pharmacokinetic profile of HM61713 and its metabolites after oral administration * To investigate biomarkers related to the safety and efficacy of HM61713
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Seoul, , Korea, Republic of
Contact Details
Name: Dong-Wan Kim, MD PhD
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
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