A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

Phase 1

Terminated

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

• Registration Number: NCT01506934
• Lead Sponsor: Abbott

Brief Summary

A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.

Detailed Description

This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-11
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
linifanib	linifanib	Single Doses

Primary Outcome Measures

Name	Time	Method
Calculate the Cmax and Tmax of participating subjects	PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period.

Secondary Outcome Measures

Name	Time	Method
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.	All adverse events occuring from Day 1 of Period 1 through the Final Visit will be reported.	The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis on Days 1 through 7 of Periods 1, 2 and 3. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the case report forms. All adverse events will be followed to a satisfactory clinical resolution.
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, 2 and 3 and Day 5, Period 2 (FE portion), Day 5, Period 3 (BA Portion)/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.	Screening, Day 1, Periods 1 and 2, Day 5, Period 2 (FE portion), Day 5, Period 3 (BA portion)/Final Visit and 30 day safety follow-up.	Chemistry, hematology, urinalysis lab tests

Trial Locations

Locations (4)

Site Reference ID/Investigator# 61282; 🇺🇸 Detroit, Michigan, United States

Site Reference ID/Investigator# 52122; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 51463; 🇺🇸 Lebanon, New Hampshire, United States

Site Reference ID/Investigator# 51465; 🇺🇸 Baltimore, Maryland, United States