HER2 Gene MutationPhase 2NCT02979821
Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)
A Phase 2 study testing Poziotinib in people with HER2 Gene Mutation and Adenocarcinoma Lung Stage IV, run by Korean Association for the Study of Targeted Therapy at 1 site in South Korea.
Trial summary
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HER2 Gene Mutation, Adenocarcinoma Lung Stage IV
- What is being tested?
- Poziotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- lung adenocarcinoma, stage IV
- Patients with HER2 mutation by sequencing
- Confirmed triple-negative patients with remnant tumor DNA
- Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
- ECOG performance status 0~2
- Patient with at least one measurable lesions according to RECIST
Show all 13Show fewer
- Patients who have proper organ functions as follows
- Neutrophil count: > 1,500/uL
- Platelet count: > 100,000/uL
- Hb: > 9.0g/dL
- AST/ALT : < 2.0 x upper normal limit
- Bilirubin: < 1.25 x upper normal limit
- Serum creatinine : < upper normal limit
Who cannot join
- Expected lie expectancy < 3 months
- CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
- Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Patients who have histories of previous exposure to EGFR-TKI
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korean Association for the Study of Targeted Therapy
Seoul
About this study
Official title: A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
Read the detailed description
This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date.
The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.
- Conditions
- HER2 Gene Mutation, Adenocarcinoma Lung Stage IV
- Being tested
- Poziotinib
- Keywords
- pan-HER inhibitor
- 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.
PoziotinibDrug
Also called NOV120101
A cycle of study treatment is defined as 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Poziotinib | Experimental | The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria. Receives: Drug: Poziotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate; ORR including rage of CR&PR
It will be assessed on based of RECIST 1.1.
Measured: through study completion (3 years)
Secondary outcomes (1)
Time to progression, TTP
from first IP administration to date of first documented progression
Measured: through study completion (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Gene MutationStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Association for the Study of Targeted Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Konkuk University Medical Center, Kyungpook National University Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Chungnam National University Hospital
- Responsible party
- Sponsor
- Investigators
- Kye-Young, Lee, MD, PhD, Principal investigator, Kunkok University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979821
- Sponsor's protocol ID
- PZT1401
- Status last verified
- May 2018
- First submitted
- 24 Nov 2016
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation
- ClinicalTrials.gov ID
- NCT02979821
- Acronym / sponsor ID
- PZT1401
- Conditions
- HER2 Gene Mutation, Adenocarcinoma Lung Stage IV
- Keywords
- pan-HER inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Korean Association for the Study of Targeted TherapyUniversity, hospital or other
- Collaborators
- Konkuk University Medical Center, Kyungpook National University Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Chungnam National University Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Dec 2016 (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.
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
Detailed description
This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date.
The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poziotinib | Experimental | Drug: PoziotinibThe study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- lung adenocarcinoma, stage IV
- Patients with HER2 mutation by sequencing
- Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
- ECOG performance status 0~2
- Patient with at least one measurable lesions according to RECIST
Key exclusion criteria (4 listed)
- Expected lie expectancy < 3 months
- CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
- Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Patients who have histories of previous exposure to EGFR-TKI
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 |
|---|---|---|
| PoziotinibAlso: NOV120101A cycle of study treatment is defined as 28 days. | Drug | Poziotinib |
Primary outcome
Objective Response Rate; ORR including rage of CR&PR
Time frame: through study completion (3 years)
It will be assessed on based of RECIST 1.1.
1 secondary outcome
Time to progression, TTP
Time frame: through study completion (3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Kye-Young, Lee, MD, PhD principal investigator
Kunkok University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Poziotinib in people with HER2 Gene Mutation and Adenocarcinoma Lung Stage IV, run by Korean Association for the Study of Targeted Therapy at 1 site 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 including rage of CR&PR (time frame: through study completion (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 24 May 2018.