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

NCT02979821 | Completed Phase 2

• 1 other identifier: PZT1401
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HER2 Gene Mutation; Adenocarcinoma Lung Stage IV

Keywords

pan-HER inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to progression, TTP

  through study completion (3 years)

Study Arms (1)

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.

Drug: Poziotinib

Interventions

Poziotinib DRUG

A cycle of study treatment is defined as 28 days.

Also known as: NOV120101

Poziotinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Association for the Study of Targeted Therapy: lead
• Konkuk University Medical Center: collaborator
• Kyungpook National University Hospital: collaborator
• Kosin University Gospel Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Chungnam National University Hospital: collaborator

Study Sites (1)

Korean Association for the Study of Targeted Therapy

Seoul, South Korea

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

HM781-36B

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Kye-Young, Lee, MD, PhD

  Kunkok University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 2, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

KR (1)