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

Completed · Phase 1

Conditions studied: Neoplasm Metastases, Hepatic Insufficiency

In brief

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.

Key facts

Study ID

NCT01273493

Run by

Janssen Research & Development, LLC

People needed

15

Starts

2010-12-01

Expected to finish

2014-04-01

Last updated by the study team

2016-02-15

Who can join

Age: 18 and older, up to 70. 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 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Detroit, Michigan, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Tacoma, Washington, United States
• Study site — Edegem, Belgium
• Study site — Wilrijk, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — Barcelona, Spain
• Study site — Madrid, Spain

Full record on ClinicalTrials.gov

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