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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.

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

Details

• Lead Sponsor: Eisai Inc.

Criteria

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.