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A pharmacokinetic study to compare 2 clinical formulations of linifanib.
This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linifanib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linifanib | Drug | QD on Day 1 of Periods 1 and 2 |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors. | Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed. | At various time points from Day 1 through Day 5 of Periods 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. | The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. | Throughout 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. |
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Inclusion Criteria
Age is greater than or equal to 18 years.
Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
Subject must have adequate bone marrow, renal and hepatic function as follows:
Subject must have Partial Thromboplastin Time (PTT) \
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| Name | Affiliation | Role |
|---|---|---|
| Mark D. McKee, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 51403 | Tacoma | Washington | 98405 | United States |
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| ID | Term |
|---|---|
| C513486 | linifanib |
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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. |
| 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. |
| Safety: Clinical Lab Tests will be performed for each participant as a safety measure. | Chemistry, hematology, urinalysis lab tests | Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up. |