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Study of Poziotinib in Japanese Patients With NSCLC

NCT04402008 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-06-25

Study results available
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Summary

A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).

Conditions

Interventions

DRUG

Poziotinib Once Daily Dosing

The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.

DRUG

Poziotinib Twice Daily Dosing

The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.

DRUG

Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1

The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2023-02-15
Completion
2023-02-15
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402008 on ClinicalTrials.gov