An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVENTM 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 greater than or equal to 80 mL/min.

- Moderate impairment - creatinine clearance >30 to 50 mL/min.

- Severe impairment - creatinine clearance 15 to less than 30 mL/min.

- Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the
upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase
(ALT), and aspartate aminotransferase (AST) less than or equal to 3 times the ULN (in
the case of liver metastasis less than or equal to 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 greater than 50 to less
than 80 mL/min).

- Subjects with end stage renal disease (creatinine clearance less than 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.