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

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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