NCT02979821

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Korean Association for the Study of Targeted Therapy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HER2 Gene Mutation
• Adenocarcinoma Lung Stage IV

Interventions

Type	Name	Description
DRUG	Poziotinib	A cycle of study treatment is defined as 28 days.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-12-02
• Last updated: 2018-05-24

Locations

1 site across 1 country: South Korea