Back to resultsAn Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
Primary Purpose
Unspecified Adult Solid Tumor, Protocol Specific
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E7389
E7389
E7389
Sponsored by
About this trial
This is an interventional treatment trial for Unspecified Adult Solid Tumor, Protocol Specific focused on measuring Unspecified Advance Solid Tumor, Protocol Specific
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Safety data that will be evaluated include adverse events, clinical laboratory results, physical examination results, ECG, and vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01418677
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
Unspecified Advance Solid Tumor, Protocol Specific
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Title
Cohort 3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
E7389
Other Intervention Name(s)
Halaven
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
E7389
Other Intervention Name(s)
Halaven
Intervention Description
Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.
Intervention Type
Drug
Intervention Name(s)
E7389
Other Intervention Name(s)
Halaven
Intervention Description
Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.
Primary Outcome Measure Information:
Title
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.
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.
Time Frame
Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Secondary Outcome Measure Information:
Title
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.
Description
Safety data that will be evaluated include adverse events, clinical laboratory results, physical examination results, ECG, and vital signs
Time Frame
Halaven will be measured on Day 1 and 8 of a 21 day cycle.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Duarte
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26433580
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.
Results Reference
derived
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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
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