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

Stopped early · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.

Key facts

Study ID

NCT01506934

Run by

Abbott

People needed

14

Starts

2011-10-01

Expected to finish

2012-01-01

Last updated by the study team

2012-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 51465 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 61282 — Detroit, Michigan, United States
• Site Reference ID/Investigator# 51463 — Lebanon, New Hampshire, United States
• Site Reference ID/Investigator# 52122 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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