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

Primary Purpose

HER2 Gene Mutation, Adenocarcinoma Lung Stage IV

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Poziotinib
Sponsored by
Korean Association for the Study of Targeted Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Gene Mutation focused on measuring pan-HER inhibitor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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

Sites / Locations

  • Korean Association for the Study of Targeted Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Poziotinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate; ORR including rage of CR&PR
It will be assessed on based of RECIST 1.1.

Secondary Outcome Measures

Time to progression, TTP
from first IP administration to date of first documented progression

Full Information

First Posted
November 24, 2016
Last Updated
May 23, 2018
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
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1. Study Identification

Unique Protocol Identification Number
NCT02979821
Brief Title
Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)
Official Title
A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Gene Mutation, Adenocarcinoma Lung Stage IV
Keywords
pan-HER inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Poziotinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Poziotinib
Other Intervention Name(s)
NOV120101
Intervention Description
A cycle of study treatment is defined as 28 days.
Primary Outcome Measure Information:
Title
Objective Response Rate; ORR including rage of CR&PR
Description
It will be assessed on based of RECIST 1.1.
Time Frame
through study completion (3 years)
Secondary Outcome Measure Information:
Title
Time to progression, TTP
Description
from first IP administration to date of first documented progression
Time Frame
through study completion (3 years)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kye-Young, Lee, MD, PhD
Organizational Affiliation
Kunkok University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korean Association for the Study of Targeted Therapy
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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