Clinical trial NCT01418677: An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
Official title: An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: Unspecified Advance Solid Tumor, Protocol Specific
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and 8 of a 21-day cycle.


Eligibility 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.

Primary outcomes:
measure: To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
timeFrame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability of HALAVEN in subjects with moderate or severe renal impairment, as well as in those with normal renal function.
timeFrame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Other outcomes:
Locations:
city: Duarte
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: New Brunswick
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
Study officials:
References:
citation: Tan AR, Sarantopoulos J, Lee L, Reyderman L, He Y, Olivo M, Goel S. Pharmacokinetics of eribulin mesylate in cancer patients with normal and impaired renal function. Cancer Chemother Pharmacol. 2015 Nov;76(5):1051-61. doi: 10.1007/s00280-015-2878-5. Epub 2015 Oct 3.