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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01819428
Recruitment Status : Terminated (Low recruitment)
First Posted : March 27, 2013
Last Update Posted : March 1, 2016
Hanmi Pharmaceutical Company Limited
Information provided by (Responsible Party):
National OncoVenture

Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Lung Stage IIIB Adenocarcinoma of Lung Stage IV Drug: NOV120101 (Poziotinib) Phase 2

Detailed Description:
EGFR TKIs are known as more effective and less toxic medications against EGFR mutated tumors. However, newly acquired resistance to these inhibitors is the inevitable obstacle in continuous treatment with them. To overcome this problem, many new class of TKIs including NOV120101 (Poziotinib) are developing these days. To evaluate the efficacy of NOV120101 (Poziotinib) as a first-line monotherapeutic medication, chemotherapy-naïve patients will participate in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily until disease progression or unacceptable toxicity development. Objective response rate (ORR) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 months, DCR, PFS, and OS will also be analyzed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Single Arm, Multi-center, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) as the First-line Treatment Medication in Patients With Harboring EGFR Mutations
Study Start Date : March 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NOV120101 (Poziotinib)
Single arm study with NOV120101(poziotinib)12mg PO daily administration
Drug: NOV120101 (Poziotinib)
NOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity development
Other Names:
  • HM781-36B
  • Poziotinib

Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: about 3 years ]
    the proportion of patients with complete response (CR) and/or partial response (PR)

Secondary Outcome Measures :
  1. Progression free survival (PFS) rate at 12 months [ Time Frame: 12 months after enrollment of the last subject ]
    the proportion of patients with complete response (CR) and/or partial response (PR) at 12 months following start of study drug administration.

  2. Disease control rate (DCR) [ Time Frame: 3 years ]
    the proportion of patients with CR, PR and/or stable disease (SD)

  3. Progression free survival (PFS) [ Time Frame: 3 years ]
    The length of time during and after medication or treatment during which the disease being treated (usually cnacer) does not get worse.

  4. Overall survival (OS) [ Time Frame: 3 years ]
    the time from study drug administration until death from any cause

  5. Change of quality of life (QoL) measured by EQ-5D questionnaire [ Time Frame: 3 years ]
    Change means the end of treatment minus baseline in each patient

Other Outcome Measures:
  1. Population pharmacokinetics (PK) of NOV120101 (Poziotinib) [ Time Frame: 3 months after enrollment of the last subject ]
    to observe pharmacokinetic parameter, inter-individual variability and intra-individual variability considering covariates, demographic factors, influencing PK profile.

  2. Subgroup analyses according to the genetic information [ Time Frame: 3 years ]
    to observe HGF expression status in plasma and T790M mutation induction status from plasma DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients aged 20 years or older
  2. Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarcinoma
  3. Documented EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, etc.) with tumor tissue
  4. Patients who have 1 or more measurable lesions according to RECIST version 1.1
  5. ECOG performance status 2 or less
  6. Life expectancy of 12 weeks or more
  7. Patients who have adequate hematological, hepatic and renal functions; WBC 4,000 or more per mm3, platelet 100,000 or more per mm3, serum creatinine 1.5 times or less upper limit of normal, AST and ALT 2.5 times or less upper limit of normal, total bilirubin 1.5 times or less upper limit of normal
  8. Patients who give written informed consent voluntarily

Exclusion Criteria:

  1. Prior systemic chemotherapy, immunotherapy or biological therapy for stage IIIB or IV adenocarcinoma (However, neo or adjuvant chemo, chemoradio or radiotherapy is permitted if at least 6 months has elapsed prior to disease progression)
  2. Prior treatment with small molecules or antibodies targeting EGFR
  3. Patients who received major surgery within 4 weeks before study drug administration
  4. Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 2 weeks are able to participate in this trial.)
  5. History of other malignancies except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for 3 years or more and considered to be cured by investigator's judgment
  6. Known preexisting interstitial lung disease (ILD)
  7. NYHA class III or IV heart failure, uncontrolled hypertension, unstable angina or myocardial infarction within 6 months, poorly controlled arrhythmia or other clinically significant cardiovascular abnormalities at investigator's discretion
  8. Patients whose left ventricle ejection fraction (LVEF) is below the institutional lower limit of normal (if no lower limit of normal is defined in the site, the lower limit is 50 percent)
  9. Patients with known active hepatitis B, HIV infection, or other uncontrolled infectious disease
  10. Clinically significant or recent acute gastrointestinal disorders with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption disorders, CTCAE grade 2 diarrhea or more due to any etiology)
  11. Patients who cannot receive IP by mouth and be diagnosed with clinically significant gastrointestinal disorders which can prevent administration, transit or absorption of the study drug
  12. Pregnancy or breast feeding
  13. Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
  14. Patients who received other investigational products except gefitinib and erlotinib within 4 weeks before participation
  15. Patients who cannot participate in this trial by investigator's judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01819428

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Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Gachon University Gil Hospital
Namdong-Gu, Incheon,, Korea, Republic of, 405-760
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of, 110-744
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 136-738
Ulsan University Hospital
Dong-gu, Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
National OncoVenture
Hanmi Pharmaceutical Company Limited
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Study Director: Jungyong Kim, MD National OncoVenture
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Responsible Party: National OncoVenture Identifier: NCT01819428    
Other Study ID Numbers: NOV120101-201
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Keywords provided by National OncoVenture:
EGFR mutation
Lung Adenocarcinoma
Firstline therapy
Second generation of tyrosine kinase
Additional relevant MeSH terms:
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Adenocarcinoma of Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site