NCT01418677View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

July 31, 2014

Study Completion Date

May 31, 2015

Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
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).

DRUG

E7389

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

DRUG

E7389

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

Trial Locations (9)

Unknown

Duarte

Miami

Atlanta

Detroit

Minneapolis

St Louis

New Brunswick

The Bronx

San Antonio

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01418677 - An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function | Biotech Hunter | Biotech Hunter