NCT03804515

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

A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, open-label, single-dose study of 14C-labeled poziotinib 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. On Day 1, enrolled patients will be admitted to the inpatient unit and all predose assessments will be completed. Patients will be admitted to the inpatient unit for 9 days. On Day 2, a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally in the morning right after breakfast with at least 200 mL of water. Over the following 168 hours, urine and feces will be collected and pooled at specified intervals for measurement of total radioactivity recovered and subsequent determination of the routes of elimination of poziotinib and its metabolites. Blood samples will be taken at specified time points for 168 hours after dosing for estimation of single-dose poziotinib PK parameters.

Conditions

• Solid Tumor

Interventions

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

Timeline

• Start date: 2019-06-25
• Primary completion: 2020-02-20
• Completion: 2020-06-17
• First posted: 2019-01-15
• Last updated: 2021-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study