An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01413893|
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: linifanib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Other Name: ABT-869
- 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. ]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. ]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 ]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 ]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.
- There are no secondary outcome measures specified for this study. [ Time Frame: There are no secondary outcome measures specified for this study. ]There are no secondary outcome measures specified for this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413893
|Study Director:||Mark D. McKee, MD||Abbott|