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

Completed · Phase 1

Conditions studied: Neoplasm Metastases

In brief

The purpose of this study is to evaluate the potential effects of rifampin on blood levels of trabectedin after administration to patients with advanced malignancies.

Key facts

Study ID: NCT01273480
Run by: Janssen Research & Development, LLC
People needed: 12
Starts: 2010-12-01
Expected to finish: 2012-10-01
Last updated by the study team: 2014-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with locally advanced or metastatic disease, any solid tumor except hepatocellular carcinoma, who have 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
Patients with Eastern Cooperative Oncology Group (ECOG) score of <=2
Patients able to receive dexamethasone
Patients with hepatic function variables: total bilirubin <=upper limit of normal (ULN), alkaline phosphatase (ALP) <=1.5 ULN and liver function test results (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of <=2.5x ULN

You may not qualify if…

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
Patients unable to have a central catheter

Where it is running

Study site — Philadelphia, Pennsylvania, United States
Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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