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Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

NCT03318939 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2024-04-03

No results posted yet for this study

Summary

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

Conditions

Interventions

DRUG

Poziotinib

The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. * Cohorts 1-3: 16 mg QD * Cohort 4: 8 mg BID * Cohort 5: randomized to 8 mg BID or 6 mg BID or 10 mg QD * Cohorts 6 and 7: 8 mg BID

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2023-04-03
Completion
2023-04-03
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Israel
  • Italy
  • Netherlands
  • Spain

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 NCT03318939 on ClinicalTrials.gov