A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Neoplasm Metastases
Interventions
DRUG

Trabectedin

Patients will receive trabectedin 1.3 mg/m2 when given alone and 0.2mg/m2 when given with ketoconazole, intravenously (into a vein) for 3-hour.

DRUG

Ketoconazole

Patients will receive ketoconazole 1 X 200 mg tablet, two times a day, orally (by mouth)

DRUG

Dexamethasone or equivalent steroid

Patients will receive dexamethasone 20 mg or equivalent steroid intravenously, 30 minutes before trabectedin in each cycle.

Trial Locations (2)

Unknown

Brussels

Wilrijk

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaMar

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY