Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1, open-label study designed to determine the interaction of rifampin with linifanib.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Rifampin

Criteria

Inclusion Criteria

1. Age is greater than or equal to 18 years.

2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than HCC.

3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

4. Subject must have adequate bone marrow, renal and hepatic function.

• Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm^3 (1.5 X 10^9/L); Platelets >= 75,000/mm^3 (75 X 10^9/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).

5. Subject must have Partial Thromboplastin Time (PTT)ULN) and International Normalized Ratio (INR) Exclusion Criteria

1. 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.

2. Subject has undergone major surgery within 21 days of Study Day 1.

3. 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).

4. Subject has received potential inhibitors of the metabolism of linifanib within 21 days prior to initial study drug administration. Such drugs include CYP3A inhibitors, CYP1A2 inhibitors, CYP2C19 inhibitors, CYP2C8 substrates and CYP3A inducers.

5. Current enrollment in another clinical trial..