Adenocarcinoma of Lung Stage IIIBPhase 2NCT01819428
NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma
A Phase 2 study testing NOV120101 (Poziotinib) in people with Adenocarcinoma of Lung Stage IIIB and Adenocarcinoma of Lung Stage IV, run by National OncoVenture at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adenocarcinoma of Lung Stage IIIB, Adenocarcinoma of Lung Stage IV
- What is being tested?
- NOV120101 (Poziotinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Mar 2013to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Ulsan University Hospital
Dong-gu, Ulsan, 682-714
Samsung Medical Center
Gangnam-gu, Seoul, 135-710
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Seoul National University Hospital
Jongno-gu, Seoul, 110-744
Gachon University Gil Hospital
Namdong-Gu, Incheon, 405-760
Asan Medical Center
Songpa-gu, Seoul, 136-738
About this study
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
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.
Read the 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.
- Being tested
- NOV120101 (Poziotinib)
- Keywords
- EGFR mutation, Lung Adenocarcinoma, Firstline therapy, Second generation of tyrosine kinase
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOV120101 (Poziotinib)Drug
Also called HM781-36B, Poziotinib
NOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity development
| Study group | Role | What they receive |
|---|---|---|
| NOV120101 (Poziotinib) | Experimental | Single arm study with NOV120101(poziotinib)12mg PO daily administration Receives: Drug: NOV120101 (Poziotinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
the proportion of patients with complete response (CR) and/or partial response (PR)
Measured: about 3 years
Secondary outcomes (5)
Progression free survival (PFS) rate at 12 months
the proportion of patients with complete response (CR) and/or partial response (PR) at 12 months following start of study drug administration.
Measured: 12 months after enrollment of the last subject
Disease control rate (DCR)
the proportion of patients with CR, PR and/or stable disease (SD)
Measured: 3 years
Progression free survival (PFS)
The length of time during and after medication or treatment during which the disease being treated (usually cnacer) does not get worse.
Measured: 3 years
Overall survival (OS)
the time from study drug administration until death from any cause
Measured: 3 years
Change of quality of life (QoL) measured by EQ-5D questionnaire
Change means the end of treatment minus baseline in each patient
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Lung Stage IIIBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National OncoVenture
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Responsible party
- Sponsor
- Investigators
- Jungyong Kim, MD, Study director, National OncoVenture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819428
- Sponsor's protocol ID
- NOV120101-201
- Status last verified
- Feb 2016
- First submitted
- 14 Mar 2013
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01819428
- Acronym / sponsor ID
- NOV120101-201
- Keywords
- EGFR mutation, Lung Adenocarcinoma, Firstline therapy, Second generation of tyrosine kinase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National OncoVentureUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOV120101 (Poziotinib) | Experimental | Drug: NOV120101 (Poziotinib)Single arm study with NOV120101(poziotinib)12mg PO daily administration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOV120101 (Poziotinib)Also: HM781-36B, PoziotinibNOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity development | Drug | NOV120101 (Poziotinib) |
Primary outcome
Objective response rate (ORR)
Time frame: about 3 years
the proportion of patients with complete response (CR) and/or partial response (PR)
5 secondary outcomes
Progression free survival (PFS) rate at 12 months
Time frame: 12 months after enrollment of the last subject
Disease control rate (DCR)
Time frame: 3 years
Progression free survival (PFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Change of quality of life (QoL) measured by EQ-5D questionnaire
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jungyong Kim, MD study director
National OncoVenture
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOV120101 (Poziotinib) in people with Adenocarcinoma of Lung Stage IIIB and Adenocarcinoma of Lung Stage IV, run by National OncoVenture at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: about 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.