Trial | NCT02979821  Report issue

Title

Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)
A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    poziotinib ...

  • Study Participants

    6
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
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 Started
Oct 31
2016
Primary Completion
Dec 31
2017
Study Completion
Dec 31
2017
Last Update
May 24
2018

Drug Poziotinib

A cycle of study treatment is defined as 28 days.

  • Other names: NOV120101

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.

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
No Results Posted