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

This study is currently recruiting participants.
Verified February 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01418677
First received: August 1, 2011
Last updated: February 19, 2013
Last verified: February 2013
History of Changes

August 1, 2011
February 19, 2013
August 2011
August 2013   (final data collection date for primary 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. [ Time Frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01418677 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle. ] [ Designated as safety issue: Yes ]
Safety data that will be evaluated include adverse events, clinical laboratory results, physical examination results, ECG, and vital signs
Same as current
Not Provided
Not Provided
 
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN™ in Subjects With Cancer Who Also Have Impaired Renal Function
An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN™ in Subjects With Cancer Who Also Have Impaired Renal Function

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: E7389
    Severe renal impairment—the dose to be administered will be based on the interim analyses of safety and pharmacokinetics in subjects with moderate renal impairment (Cohort 1).
    Other Name: Halaven
  • Drug: E7389
    Moderate renal impairment—HALAVEN will be dosed at 1.4 mg/m2.
    Other Name: Halaven
  • Drug: E7389
    Normal renal function—HALAVEN will be dosed at 1.4 mg/m2.
    Other Name: Halaven
  • Active Comparator: Cohort 1
    Intervention: Drug: E7389
  • Active Comparator: Cohort 2
    Intervention: Drug: E7389
  • Active Comparator: Cohort 3
    Intervention: Drug: E7389
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
Not Provided
August 2013   (final data collection date for primary outcome measure)

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 ≥80 mL/min.
    • Moderate impairment - creatinine clearance > 30 to 50 mL/min.
    • Severe impairment - creatinine clearance 15 to <30 mL/min.
  • Adequate liver function as evidenced by bilirubin ≤1.5 times the upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 times the ULN (in the case of liver metastasis ≤ 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 > 50 to <80 mL/min).
  • Subjects with end stage renal disease (creatinine clearance < 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.
Both
18 Years and older
No
Contact: Eisai Medical Services 1-888-422-4743
United States
 
NCT01418677
E7389-A001-106
No
Eisai Inc.
Eisai Inc.
Not Provided
Not Provided
Eisai Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP