NCT02674555

A Study to Investigate the Absorption, Metabolism and Excretion of [14C]ASP8273 in Subjects With Solid Tumors

A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]ASP8273 in Subjects With Solid Tumors Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to investigate the absorption, metabolism and excretion of \[14C\] labeled ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This study consists of two parts (A and B).

Detailed description

This study consists of two parts (A and B). In Part A, eligible subjects will be admitted to the site on day -1 and remain confined at the site until postdosing discharge criteria are met. Subjects will receive a single dose of \[14C\] ASP8273 solution on study day 1. Once Part A has been completed, subjects may elect to continue participation in Part B. Subjects will receive oral administration of ASP8273 (nonradiolabeled) once daily in 28-day cycles.

Conditions

• Epidermal Growth Factor Receptor (EGFR) Mutations
• Solid Tumors

Interventions

Type	Name	Description
DRUG	radio-labeled naquotinib	Oral administration
DRUG	naquotinib	Oral administration

Timeline

• Start date: 2016-11-15
• Primary completion: 2016-11-15
• Completion: 2016-11-15
• First posted: 2016-02-04
• Last updated: 2017-07-28