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

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Brief Title

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

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

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate (ORR)

Secondary Outcome

 Progression free survival (PFS) rate at 12 months

Condition

Adenocarcinoma of Lung Stage IIIB

Intervention

NOV120101 (Poziotinib)

Study Arms / Comparison Groups

 NOV120101 (Poziotinib)
Description:  Single arm study with NOV120101(poziotinib)12mg PO daily administration

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

22

Start Date

March 2013

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jungyong Kim, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01819428

Organization ID

NOV120101-201


Responsible Party

Sponsor

Study Sponsor

National OncoVenture

Collaborators

 Hanmi Pharmaceutical Company Limited

Study Sponsor

Jungyong Kim, MD, Study Director, National OncoVenture


Verification Date

February 2016