NCT01588145

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

Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HM61713 in NSCLC Patients With EGFR Mutation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HM61713	BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2012-04-30
• Last updated: 2018-04-24

Locations

1 site across 1 country: South Korea