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