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NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors

NCT01718847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-08-14

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 2nd line monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs).

Conditions

  • Increased Drug Resistance

Interventions

DRUG

NOV120101 (Poziotinib)

16 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

  • Ji-Youn Han, MD. Ph.D · National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea,Asan Medical Center, Songpa-gu, Seoul, Republic of Korea,

  • Ki Hyeong Lee, MD, Ph.D · Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Republic of Korea

  • Sang-We Kim, MD, Ph.D · Asan Medical Center, Songpa-gu, Seoul, Republic of Korea

  • Young Joo Min, MD, Ph.D · Ulsan University Hospital, Dong-gu, Ulsan, Republic of Korea

  • Eunkyung Cho, MD, Ph.D · Gachon University Gil Medical Center, Incheon, Republic of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT01718847 on ClinicalTrials.gov