NCT02485652

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

A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Detailed description

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HM61713	800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.

Timeline

• Start date: 2015-08-31
• Primary completion: 2020-12-08
• Completion: 2020-12-08
• First posted: 2015-06-30
• Last updated: 2021-01-22

Locations

72 sites across 10 countries: United States, Australia, Canada, Germany, Italy, Malaysia, Philippines, South Korea, Spain, Taiwan