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

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

NOV120101 (Poziotinib)

Jungyong Kim, MD

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.

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.

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

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

to observe pharmacokinetic parameter, inter-individual variability and intra-individual variability considering covariates, demographic factors, influencing PK profile.

to observe HGF expression status in plasma and T790M mutation induction status from plasma DNA

the proportion of patients with complete response (CR) and/or partial response (PR)

the proportion of patients with complete response (CR) and/or partial response (PR) at 12 months following start of study drug administration.

the proportion of patients with CR, PR and/or stable disease (SD)

The length of time during and after medication or treatment during which the disease being treated (usually cnacer) does not get worse.

the time from study drug administration until death from any cause

Change means the end of treatment minus baseline in each patient

Hanmi Pharmaceutical Company Limited

National OncoVenture

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Single arm study with NOV120101(poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval

NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval between cycles until disease progression or unacceptable toxicity development

The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who received at least 2 prior HER2-directed regimens.

To evaluate the efficacy of NOV120101 (Poziotinib) as a therapeutic agent for HER2-overexpressed recurrent stage IV breast cancer, patients who have received at least two prior HER2-directed regimens will be enrolled in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by 1-week drug-free intervals between cycles until disease progression or unacceptable toxicity development. Progression Free Survival (PFS) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 weeks, ORR, DCR, OS and TTP will also be analyzed.

Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens

A Prospective, Open-label, Single-arm, Multi-Center, Phase II Trial of NOV120101 in Patients With HER2-overexpressed Recurrent Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens

the proportion of patients with CR, PR and/or stable disease (SD)\] \[Safety Issue?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma	NCT01819428	Adenocarcinoma ... Adenocarcinoma ...	NOV120101 (Pozi...	20 Years -	National OncoVenture
NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma	NCT01819428	Adenocarcinoma ... Adenocarcinoma ...	NOV120101 (Pozi...	20 Years -	National OncoVenture
Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens	NCT02418689	Metastatic Brea...	NOV120101 (Pozi...	19 Years -	Hanmi Pharmaceutical Company Limited
Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens	NCT02418689	Metastatic Brea...	NOV120101 (Pozi...	19 Years -	Hanmi Pharmaceutical Company Limited

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