A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: ABT-869, linifanib; Drug: [14C]linifanib

• Registration Number: NCT01286974
• Lead Sponsor: Abbott

Brief Summary

A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.

Detailed Description

This study is designed to assess the mass balance of \[14C\]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. Subjects may continue on linifanib after completion of the metabolism study. The results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.

Study Timeline

• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-02-01
• Study Start: 2011-08
• Primary Completion: 2012-08
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-19
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extension	ABT-869, linifanib	linifanib
ADME	[14C]linifanib	\[14C\]linifanib

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Profile	Various timepoints from Day 1 through approximately Day 9	Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.
Total radioactivity	Various timepoints from Day 1 through approximately Day 9	Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.

Secondary Outcome Measures

Name	Time	Method
Safety (Number of subjects with adverse events and/or dose-limiting toxicities)	At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment)	Adverse event monitoring, lab test assessments, physical exam and vital signs will be evaluated throughout the study.

Trial Locations

Locations (2)

Site Reference ID/Investigator# 40942; 🇺🇸 Cleveland, Ohio, United States

Site Reference ID/Investigator# 53663; 🇺🇸 Cleveland, Ohio, United States