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
1 other identifier
interventional
19
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2011
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 17, 2016
May 1, 2016
2.8 years
August 1, 2011
May 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Secondary Outcomes (1)
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.
Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Study Arms (3)
Cohort 1
ACTIVE COMPARATORCohort 2
ACTIVE COMPARATORCohort 3
ACTIVE COMPARATORInterventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (9)
Unknown Facility
Duarte, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
San Antonio, Texas, United States
Related Publications (1)
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.
PMID: 26433580DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 17, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2014
Study Completion
May 1, 2015
Last Updated
May 17, 2016
Record last verified: 2016-05