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

NCT02485652 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2021-01-22

No results posted yet for this study

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).

Conditions

  • Non Small Cell Lung Cancer

Interventions

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.

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Keunchil Park, M.D., Ph.D · Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea

  • Pasi A. Jänne, M.D., Ph.D · Dana-Farber Cancer Institute, Boston, MA, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-12-08
Completion
2020-12-08

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Malaysia
  • Philippines
  • South Korea
  • Spain
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485652 on ClinicalTrials.gov