An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN™ in Subjects With Cancer Who Also Have Impaired Renal Function

Inclusion Criteria:

• Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).

• Renal function must fall into one of the following categories:

  • Normal function - creatinine clearance ≥80 mL/min.
  • Moderate impairment - creatinine clearance > 30 to 50 mL/min.
  • Severe impairment - creatinine clearance 15 to <30 mL/min.
• Adequate liver function as evidenced by bilirubin ≤1.5 times the upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 times the ULN (in the case of liver metastasis ≤ 5 times ULN). In the case ALP > 3 times the ULN (in the absence of liver metastasis) or > 5 times the ULN (in the presence of liver metastasis), and the subject is also known to have bone metastasis, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP.

Exclusion Criteria:

• Subjects with mild renal impairment (creatinine clearance > 50 to <80 mL/min).
• Subjects with end stage renal disease (creatinine clearance < 15 mL/min or on dialysis).
• Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivatives.
• Subjects with prior participation in an HALAVEN clinical study, even if not previously assigned to HALAVEN treatment.
• Radiation therapy encompassing > 30 % of bone marrow.
• Subjects with organ allografts requiring immunosuppression.