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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate; ORR including rage of CR&PR
Secondary Outcome
Time to progression, TTP
Condition
HER2 Gene Mutation
Intervention
Poziotinib
Study Arms / Comparison Groups
Poziotinib
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
October 2016
Completion Date
December 2017
Primary Completion Date
December 2017
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Kye-Young, Lee, MD, PhD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02979821
Organization ID
PZT1401
Responsible Party
Sponsor
Study Sponsor
Korean Association for the Study of Targeted Therapy
Collaborators
Konkuk University Medical Center
Study Sponsor
Kye-Young, Lee, MD, PhD, Principal Investigator, Kunkok University Medical Center
Verification Date
May 2018