Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1, open-label study designed to determine the interaction of rifampin with linifanib.
This study is designed to explore the drug interaction between rifampin and linifanib to determine the potential effect of rifampin on the metabolism of linifanib. Linifanib will be taken alone or in combination with rifampin. The safety of a single dose administration of linifanib when administered alone and in combination with rifampin will be assessed. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linifanib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linifanib | Drug | QD on Days 1 and 13 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of rifampin on the pharmacokinetic of linifanib in subjects with advanced or metastatic solid tumors. | To assess the effect of rifampin on the pharmacokinetics of linifanib and metabolite(s), an analysis will be performed for the natural logarithms of Cmax and AUC of linifanib and metabolite(s) with concentrations that permit confident determination of values of the pharmacokinetic variables. A paired t-test will be performed to compare the central value on Study Day 13 (with rifampin) to that on Study Day 1 (without rifampin). Point estimates and 90% confidence intervals will also be provided. | Blood samples for the PK of linifanib will be collected at various time points from Day 1 through Day 17. |
| 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. | 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. |
Not provided
Inclusion Criteria
Age is greater than or equal to 18 years.
Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than HCC.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
Subject must have adequate bone marrow, renal and hepatic function.
Subject must have Partial Thromboplastin Time (PTT) \
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark D. McKee, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 49953 | Tucson | Arizona | 85724-5024 | United States | ||
| Site Reference ID/Investigator# 49952 |
Not provided
| ID | Term |
|---|---|
| C513486 | linifanib |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rifampin | Drug | QD on Days 5-16 |
|
|
Complete physical exam, including body weight, will be done at Screening and Day 1. A symptom-directed physical exam, including weight, will be done at Day 13, Day 17/Final Visit and 30 day safety follow-up. |
| Physical exam will be done at Screening, Day1, Day 13, Day 17/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, Day 13, Day 17/Final Visit and 30 day safety follow up visit. |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |