Overview

A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Collaborator:
PharmaMar
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Trabectedin
Criteria
Inclusion Criteria:

- Patients with locally advanced or metastatic disease, any solid tumor except
hepatocellular carcinoma, who have been previously treated with systemic chemotherapy
(chemotherapy administered through the blood) and who have had 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 at the time of
screening

- Patients enrolled with hepatic dysfunction must have laboratory test results for total
bilirubin of >1.5x to <=3x the upper limit of normal (ULN) and liver function tests
(alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of <8x the ULN

- Patients enrolled without hepatic dysfunction must have laboratory test results for
total bilirubin of less than the ULN, alkaline phosphatase (ALP) <=1.5x the ULN, and
AST and ALT of <=the ULN.

Exclusion Criteria:

- Patients with previous exposure to trabectedin

- Patients with known liver disease

- Patients diagnosed with hepatocellular carcinoma, or who have a history of biliary
sepsis within the past 2 years

- Patients unwilling to have a central catheter

- In hepatic dysfunction group, patients with hepatic dysfunction who have Gilbert's
syndrome. Patients signs of encephalopathy (altered brain function).