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

NCT ID: NCT01819428

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-11-30

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.

Conditions

Adenocarcinoma of Lung Stage IIIB; Adenocarcinoma of Lung Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOV120101 (Poziotinib)

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

Group Type: EXPERIMENTAL

NOV120101 (Poziotinib)

Intervention Type: DRUG

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

Interventions

NOV120101 (Poziotinib)

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

Intervention Type: DRUG

Other Intervention Names

HM781-36B; Poziotinib

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: collaborator

National OncoVenture

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jungyong Kim, MD

Role: STUDY_DIRECTOR

National OncoVenture

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Gachon University Gil Hospital

Namdong-Gu, Incheon, South Korea

Samsung Medical Center

Gangnam-gu, Seoul, South Korea

Seoul National University Hospital

Jongno-gu, Seoul, South Korea

Asan Medical Center

Songpa-gu, Seoul, South Korea

Ulsan University Hospital

Dong-gu, Ulsan, South Korea

Countries

South Korea

Other Identifiers

NOV120101-201

Identifier Type: -

Identifier Source: org_study_id