To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.
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|ClinicalTrials.gov Identifier: NCT01381341|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : March 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: linifanib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
QD on Day 1 of Periods 1 and 2
Other Name: ABT-869
- To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors. [ Time Frame: 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.
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up. ]Chemistry, hematology, urinalysis lab tests
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): NCT01381341
|United States, Washington|
|Site Reference ID/Investigator# 51403|
|Tacoma, Washington, United States, 98405|
|Study Director:||Mark D. McKee, MD||Abbott|