An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors
This study has been completed.
Information provided by (Responsible Party):
First received: June 23, 2011
Last updated: August 1, 2012
Last verified: June 2012
An extension study of linifanib in subjects with advanced or metastatic solid tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors|
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: All adverse events occuring through the Final Visit will be reported. ] [ Designated as safety issue: Yes ]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: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]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. [ Time Frame: Change from baseline to every 12 weeks ] [ Designated as safety issue: Yes ]MUGA
- Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- There are no secondary outcome measures specified for this study. [ Time Frame: There are no secondary outcome measures specified for this study. ] [ Designated as safety issue: No ]There are no secondary outcome measures specified for this study.
|Study Start Date:||June 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
This study is designed to evaluate the safety of linifanib in subjects with advanced or metastatic solid tumors.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413893
|United States, Arizona|
|Site Reference ID/Investigator# 53006|
|Tucson, Arizona, United States, 85724-5024|
|United States, Maryland|
|Site Reference ID/Investigator# 53003|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|Site Reference ID/Investigator# 62482|
|Detroit, Michigan, United States, 48201|
|United States, New Hampshire|
|Site Reference ID/Investigator# 53004|
|Lebanon, New Hampshire, United States, 03756-0001|
|United States, Texas|
|Site Reference ID/Investigator# 53007|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|Site Reference ID/Investigator# 53008|
|Tacoma, Washington, United States, 98405|
|United States, Wisconsin|
|Site Reference ID/Investigator# 53005|
|Madison, Wisconsin, United States, 53792|
Sponsors and Collaborators
|Study Director:||Mark D. McKee, MD||Abbott|