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An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVENTM in Subjects With Cancer Who Also Have Impaired Renal Function

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

- Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Description:

The primary analysis will be conducted using the dose-normalized primary PK parameters (AUC0-inf, AUC0-last, and Cmax) respectively. Relationships between each individual PK parameter and renal function (creatinine clearance) will be analyzed by linear regression models using the PK parameter as the dependent variable and renal function as the independent variable.

Outcome Time Frame:

Halaven will be measured on Day 1 and 8 of a 21 day cycle.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Advance Solid Tumor, Protocol Specific
  • Renal Insufficiency



Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Austin, Texas  78705
Hackensack, New Jersey  07601