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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01418677
First received: August 1, 2011
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: E7389
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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. [ 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.


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. [ 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


Enrollment: 19
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1 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
Active Comparator: Cohort 2 Drug: E7389
Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.
Other Name: Halaven
Active Comparator: Cohort 3 Drug: E7389
Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.
Other Name: Halaven

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418677

Locations
United States, California
Duarte, California, United States
United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
New Brunswick, New Jersey, United States
United States, New York
Bronx, New York, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01418677     History of Changes
Other Study ID Numbers: E7389-A001-106
Study First Received: August 1, 2011
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Unspecified Advance Solid Tumor, Protocol Specific

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014