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NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma

NCT01819428 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-03-01

No results posted yet for this study

Summary

The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.

Conditions

  • Adenocarcinoma of Lung Stage IIIB
  • Adenocarcinoma of Lung Stage IV

Interventions

DRUG

NOV120101 (Poziotinib)

NOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity development

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    collaborator INDUSTRY

  • National OncoVenture

    lead OTHER

Principal Investigators

  • Jungyong Kim, MD · National OncoVenture

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • South Korea

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 NCT01819428 on ClinicalTrials.gov