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CompletedNCT02979821Updated May 24, 2018

Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

A Phase 2 interventional study of Poziotinib in HER2 Gene Mutation and Adenocarcinoma Lung Stage IV, sponsored by Korean Association for the Study of Targeted Therapy. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2018-05-24.

Sponsored by Korean Association for the Study of Targeted Therapy · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Sex
All
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Study summary

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.

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Conditions studied

  • HER2 Gene Mutation
  • Adenocarcinoma Lung Stage IV

Keywords

  • pan-HER inhibitor
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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 6 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

This is the only study on the registry with Korean Association for the Study of Targeted Therapy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. lung adenocarcinoma, stage IV

  2. Patients with HER2 mutation by sequencing

    • Confirmed triple-negative patients with remnant tumor DNA
  3. Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
  4. ECOG performance status 0\~2
  5. Patient with at least one measurable lesions according to RECIST

  6. 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

Exclusion criteria

Exclusion Criteria:

  1. Expected lie expectancy \< 3 months
  2. 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)
  3. 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)
  4. Patients who have histories of previous exposure to EGFR-TKI
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Poziotinib

    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.

    Drug: Poziotinib

Interventions

  • DrugPoziotinib

    A cycle of study treatment is defined as 28 days.

    Also known as: NOV120101

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What researchers measure

Primary outcomes

  1. Objective Response Rate; ORR including rage of CR&PR

    It will be assessed on based of RECIST 1.1.

    Time frame: through study completion (3 years)

Secondary outcomes

  1. Time to progression, TTP

    from first IP administration to date of first documented progression

    Time frame: through study completion (3 years)

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Study locations

1 site
  • Korean Association for the Study of Targeted Therapy
    Seoul, Korea, Republic of
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02979821
Lead sponsor
Korean Association for the Study of Targeted Therapy
Collaborators
Konkuk University Medical Center, Kyungpook National University Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Chungnam National University Hospital
Responsible party
Sponsor
First posted
Dec 2, 2016
Start date
Oct 2016
Primary completion
Dec 2017
Completion
Dec 2017
Last update
May 24, 2018

Study contacts

Kye-Young, Lee, MD, PhD
principal investigator · Kunkok University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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