Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the potential effects of ketoconazole on blood levels of trabectedin after administration to patients with advanced malignancies.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Collaborator:
PharmaMar
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ketoconazole
Trabectedin
Criteria
Inclusion Criteria:

- Patients with locally advanced or metastatic disease, any solid tumor except
hepatocellular carcinoma (cancer of the liver), who have been relapsed or had
progressive disease following standard of care treatment with chemotherapy prior to
enrollment, or intolerant to prior standard of care treatment with chemotherapy

Exclusion Criteria:

- Patients with previous exposure to trabectedin

- Patients with cancer that has metastasized (spread) to the central nervous system

- Patients with known liver disease

- Patients who had a myocardial infarct (heart attack) within 6 months before enrollment
or who have any other clinically significant or unstable medical condition as assessed
by the Investigator