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A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib

NCT03804515 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-06-15

No results posted yet for this study

Summary

The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.

Conditions

Interventions

DRUG

14C-labeled poziotinib

a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-02-20
Completion
2020-06-17
FDA Drug
Yes

Countries

  • United States

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 NCT03804515 on ClinicalTrials.gov