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

HER2 Gene Mutation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979821
• Other study ID #: PZT1401
• Status: Completed
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: Korean Association for the Study of Targeted Therapy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma Lung Stage IV
• HER2 Gene Mutation

Intervention

Drug:
• Poziotinib
A cycle of study treatment is defined as 28 days.

Locations

Country	Name	City	State
Korea, Republic of	Korean Association for the Study of Targeted Therapy	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Korean Association for the Study of Targeted Therapy	Chonnam National University Hospital, Chungnam National University Hospital, Konkuk University Medical Center, Kosin University Gospel Hospital, Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate; ORR including rage of CR&PR	It will be assessed on based of RECIST 1.1.	through study completion (3 years)
Secondary	Time to progression, TTP	from first IP administration to date of first documented progression	through study completion (3 years)