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

NCT01819428 | Terminated Phase 2

• 1 other identifier: NOV120101-201
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

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.

Conditions

Adenocarcinoma of Lung Stage IIIB; Adenocarcinoma of Lung Stage IV

Keywords

EGFR mutation; Lung Adenocarcinoma; Firstline therapy; Second generation of tyrosine kinase

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

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

  about 3 years

Secondary Outcomes (5)

• Progression free survival (PFS) rate at 12 months

  12 months after enrollment of the last subject

• Disease control rate (DCR)

  3 years

• Progression free survival (PFS)

  3 years

• Overall survival (OS)

  3 years

• Change of quality of life (QoL) measured by EQ-5D questionnaire

  3 years

Other Outcomes (2)

• Population pharmacokinetics (PK) of NOV120101 (Poziotinib)

  3 months after enrollment of the last subject

• Subgroup analyses according to the genetic information

  3 years

Study Arms (1)

NOV120101 (Poziotinib)

EXPERIMENTAL

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

Drug: NOV120101 (Poziotinib)

Interventions

NOV120101 (Poziotinib) DRUG

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

Also known as: HM781-36B, Poziotinib

NOV120101 (Poziotinib)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 20 years or older
• Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarcinoma
• Documented EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, etc.) with tumor tissue
• Patients who have 1 or more measurable lesions according to RECIST version 1.1
• ECOG performance status 2 or less
• Life expectancy of 12 weeks or more
• 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
• Patients who give written informed consent voluntarily

You may not qualify if:

• 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)
• Prior treatment with small molecules or antibodies targeting EGFR
• Patients who received major surgery within 4 weeks before study drug administration
• 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.)
• 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
• Known preexisting interstitial lung disease (ILD)
• 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
• 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)
• Patients with known active hepatitis B, HIV infection, or other uncontrolled infectious disease
• 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)
• 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
• Pregnancy or breast feeding
• 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
• Patients who received other investigational products except gefitinib and erlotinib within 4 weeks before participation
• Patients who cannot participate in this trial by investigator's judgment

Sponsors & Collaborators

• National OncoVenture: lead
• Hanmi Pharmaceutical Company Limited: collaborator

Study Sites (6)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Gachon University Gil Hospital

Namdong-Gu, Incheon, 405-760, South Korea

Location

Samsung Medical Center

Gangnam-gu, Seoul, 135-710, South Korea

Location

Seoul National University Hospital

Jongno-gu, Seoul, 110-744, South Korea

Location

Asan Medical Center

Songpa-gu, Seoul, 136-738, South Korea

Location

Ulsan University Hospital

Dong-gu, Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

HM781-36B

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Jungyong Kim, MD

  National OncoVenture

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 27, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

KR (6)