To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: linifanib

• Registration Number: NCT01381341
• Lead Sponsor: Abbott

Brief Summary

A pharmacokinetic study to compare 2 clinical formulations of linifanib.

Detailed Description

This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
linifanib	linifanib	-

Primary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.	At various time points from Day 1 through Day 5 of Periods 1 and 2	Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.

Secondary Outcome Measures

Name	Time	Method
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.	Throughout the study	The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.	Physical exam at Screening, Day 1 of Periods 1 and 2 and Day 5, Period 2/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.	Complete physical exam, including body weight, will be done at Screening. A symptom-directed physical exam, including bodyweight, will be done at Day 1, Periods 1 and 2, Day 5, Period 2/Final Visit and 30 day safety follow-up.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.	Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up.	Chemistry, hematology, urinalysis lab tests

Trial Locations

Locations (1)

Site Reference ID/Investigator# 51403; 🇺🇸 Tacoma, Washington, United States