An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors

Phase 1

Completed

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

• Registration Number: NCT01413893
• Lead Sponsor: AbbVie

Brief Summary

An extension study of linifanib in subjects with advanced or metastatic solid tumors.

Detailed Description

This study is designed to evaluate the safety of linifanib in subjects with advanced or metastatic solid tumors.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
linifanib	linifanib	-

Primary 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 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 through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.	Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit	Chemistry, hematology, urinalysis lab tests will be measured and recorded on the case report forms. All clinically significant values will be followed by the investigator 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.	Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit.	Physical exam, blood pressure, pulse, body temperature will be measured and recorded on the case report forms.
Safety: Multiple Gated Acquisition (MUGA) will be assessed at specified time points as a measure of safety.	Change from baseline to every 12 weeks	MUGA

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures specified for this study.	There are no secondary outcome measures specified for this study.	There are no secondary outcome measures specified for this study.