- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01718847
NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors (NSCLC)
Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) in Lung Adenocarcinoma Patients With Acquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Incheon, Korea, Republic of, 405-760
- Gachon University Gil Medical Center
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Chungcheongbuk-do
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Cheongju-si,, Chungcheongbuk-do, Korea, Republic of, 361-711
- Chungbuk National University Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- National Cancer Center
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Seoul
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Songpa-gu, Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Ulsan
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Dong-gu, Ulsan, Korea, Republic of, 682-714
- Ulsan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients aged 20 years or older
- Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarinoma
- Patients who have 1 or more than 1 measurable or evaluable but unmeasurable lesions according to RECIST ver1.1
Patients who received prior 1st generation EGFR TKIs (gefitinib or erlotinib) monotherapy and meet the following criteria:
- Patients with EGFR mutation (e.g., G719X, exon 19 deletion, L858R, L861Q, etc) known to be associated with sensitivity to TKIs
Patients who showed objective clinical benefit from treatment with an EGFR TKI as defined by either:
- Patients who showed complete (CR) or partial response (PR), or
- Patients who maintained stable disease (SD) status ≥ 6 months
- Patients who showed progressive disease (PD, RECIST ver1.1) while on continuous treatment with gefitinib or erlotinib within the last 30 days (However, patients whose progressive disease is limited in the brain cannot participate in this trial.)
- No intervening systemic chemotherapy between cessation of the EGFR TKI and participation of this study
- Patients who agree to the collection of tumor tissue specimen
- ECOG performance status ≤ 2
- Life expectancy of ≥ 12 weeks
Adequate hematological, hepatic and renal functions:
WBC ≥ 4,000/mm3, Platelet ≥ 100,000/mm3, Serum creatinine ≤ 1.5 X ULN, AST and ALT ≤ 2.5 X ULN, Total bilirubin ≤ 1.5 X ULN
- Patients who give written informed consent voluntarily
Exclusion Criteria:
- Patients who receive IP within 3 days from prior treatment with gefitinib or erlotinib
- NCI-CTCAE grade > 1 adverse events due to treatment with gefitinib or erlotinib
- Prior systemic chemo, immuno, hormonal and/or biological therapy except gefitinib or erlotinib within 4 weeks before IP administration
- Acquired resistance to EGFR TKI due to conversion of adenocarcinoma into small cell lung cancer
- Patients who received major surgery within 4 weeks before IP administration
- Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 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 and considered to be cured by investigator's judgment
- Known pre-existing 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%.)
- 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 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 IP
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NOV120101 (Poziotinib)
16 mg PO once daily until disease progression or unacceptable toxicity development
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16 mg PO once daily until disease progression or unacceptable toxicity development
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: By 1 year after enrollment of the last subject
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The length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
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By 1 year after enrollment of the last subject
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS rate at 16 weeks
Time Frame: 16 weeks
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The proportion of Patients maintaining progress-free status at 16 weeks
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16 weeks
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Objective response rate (ORR)
Time Frame: By 1 year after enrollment of the last subject
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The proportion of patients with partial response or complete response at their best tumor treatment evaluation
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By 1 year after enrollment of the last subject
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Disease control rate (DCR)
Time Frame: By 1 year after enrollment of the last subject
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The proportion of patients with CR, PR and/or stable disease (SD)
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By 1 year after enrollment of the last subject
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Overall survival (OS)
Time Frame: By 1 year after enrollment of the last subject
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By 1 year after enrollment of the last subject
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Time to progression (TTP)
Time Frame: By 1 year after enrollment of the last subject
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By 1 year after enrollment of the last subject
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Time to objective response
Time Frame: By 1 year after enrollment of the last subject
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By 1 year after enrollment of the last subject
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Duration of objective response
Time Frame: By 1 year after enrollment of the last subject
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By 1 year after enrollment of the last subject
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Duration of disease control
Time Frame: By 1 year after enrollment of the last subject
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By 1 year after enrollment of the last subject
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Change of quality of life (QoL) measured by EQ-5D questionnaire
Time Frame: baseline and the end of treatment, by 1 year after enrollment of the last subject
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baseline and the end of treatment, by 1 year after enrollment of the last subject
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Population pharmacokinetics (PK) of NOV120101 (Poziotinib)
Time Frame: By 3 months after enrollment of the last subject
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The study of the sources and correlates of variability in drug concentrations among individuals who are the target patient population receiving clinically relevant doses of a study drug.
Certain patient demographic, pathophysiological, and therapeutical features, such as body weight, excretory and metabolic functions, and the presence of other therapies, can regularly alter dose-concentration relationships.
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By 3 months after enrollment of the last subject
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Subgroup analyses with the genetic information
Time Frame: by 1 year after enrollment of the last patient
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Subgroup analysis, in the context of design and analysis of study drug, refers to looking for pattern in a subset of the subjects according to genotype
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by 1 year after enrollment of the last patient
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ji-Youn Han, MD. Ph.D, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea,Asan Medical Center, Songpa-gu, Seoul, Republic of Korea,
- Principal Investigator: Ki Hyeong Lee, MD, Ph.D, Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Republic of Korea
- Principal Investigator: Sang-We Kim, MD, Ph.D, Asan Medical Center, Songpa-gu, Seoul, Republic of Korea
- Principal Investigator: Young Joo Min, MD, Ph.D, Ulsan University Hospital, Dong-gu, Ulsan, Republic of Korea
- Principal Investigator: Eunkyung Cho, MD, Ph.D, Gachon University Gil Medical Center, Incheon, Republic of Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NOV120101-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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