Status:
TERMINATED
A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Abbott
Conditions:
Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.
Detailed Description
This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. Su...
Eligibility Criteria
Inclusion
- 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:
- Bone Marrow: Absolute neutrophil count (ANC) \>= 1,500/mm3 (1.5 X 109/L); Platelets \>= 75,000/mm3 (75 X 109/L); Hemoglobin \>= 9.0 g/dL (1.4 mmol/L)
- Renal function: serum creatinine \<= 2.0 mg/dL (0.81 mmol/L);
- Hepatic function: AST and ALT \<= 1.5 X ULN unless liver metastases are present, then AST and ALT \<= 5.0 X ULN; bilirubin \<= 1.5 mg/dL (0.026 mmol/L)
- Subject must have Partial Thromboplastin Time (PTT) \</= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) \</= 1.5.
- Exclusion Criteria
- Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
- Subject has undergone major surgery within 21 days of Period 1, Study Day 1.
- Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1, Period 1).
- Current enrollment in another clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01506934
Start Date
October 1 2011
End Date
January 1 2012
Last Update
August 28 2012
Active Locations (4)
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1
Site Reference ID/Investigator# 51465
Baltimore, Maryland, United States, 21231
2
Site Reference ID/Investigator# 61282
Detroit, Michigan, United States, 48201
3
Site Reference ID/Investigator# 51463
Lebanon, New Hampshire, United States, 03756-0001
4
Site Reference ID/Investigator# 52122
San Antonio, Texas, United States, 78229