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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors

NCT00069277

Cancer

COMPLETED PHASE1

A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer

NCT00422097

Cancer

COMPLETED PHASE1

An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors

NCT01678690

Malignant Tumors

COMPLETED EARLY_PHASE1

A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589

NCT00472368

Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

COMPLETED PHASE1

Axitinib Pharmacokinetics in Chinese Healthy Volunteers

NCT00919204

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Group Type ACTIVE_COMPARATOR

E7389

Intervention Type DRUG

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).

Cohort 2

Group Type ACTIVE_COMPARATOR

E7389

Intervention Type DRUG

Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.

Cohort 3

Group Type ACTIVE_COMPARATOR

E7389

Intervention Type DRUG

Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

E7389

Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.

Intervention Type DRUG

E7389

Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Halaven Halaven Halaven

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No