Status:
COMPLETED
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
Lead Sponsor:
Eisai Inc.
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01418677
Start Date
October 1 2011
End Date
May 1 2015
Last Update
May 17 2016
Active Locations (9)
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1
Duarte, California, United States
2
Miami, Florida, United States
3
Atlanta, Georgia, United States
4
Detroit, Michigan, United States