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An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction

Phase 1
18 Years
70 Years
Open (Enrolling)
Neoplasm Metastases, Hepatic Insufficiency

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Trial Information

An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction

This is an open-label (patients will know the names of study drugs they receive),
single-dose, study that will examine the pharmacokinetics (blood levels) and assess survival
and safety of trabectedin in patients with advanced malignancies who either have hepatic
(liver) dysfunction or do not have hepatic dsyfunction (patients enrolled without hepatic
dysfunction will be referred to as the control group). Trabectedin is a drug being developed
to treat patients with cancer that will be administered intravenously (i.v.) through a
catheter (tube) into a central vein. In addition, dexamethasone, a drug used to prevent
nausea and vomiting in chemotherapy patients that may have protective effects on the liver,
will be administered to patients before the administration of trabectedin. Patients who
complete the treatment phase of the study who in the opinion of the investigator would
derive an overall clinical benefit from further treatment with trabectedin will have the
opportunity to continue treatment with trabectedin in the optional extension phase. The dose
and schedule of trabectedin may be modified by the treating physician in the optional
extension phase to be more appropriate for the type of malignancy being treated. A single
dose of trabectedin (1.3 mg/m2 in patients in the control group and 0.58 mg/m2 in patients
with hepatic dysfunction) will be administered by i.v.infusion over a 3-hour period. The
dose of trabectedin may be adjusted if necessary for patients with hepatic dysfunction
subsequently enrolled in the study. All patients will be administered dexamethasone 20 mg
i.v. (or equivalent) approximately 30 minutes before the administration of trabectedin.

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

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics of trabectedin

Outcome Time Frame:

At protocol-specified time points for up to 8 days

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

January 2015

Related Keywords:

  • Neoplasm Metastases
  • Hepatic Insufficiency
  • Trabectedin, YONDELIS
  • Antineoplastic Agents
  • Solid tumors
  • Locally advanced or metastatic disease
  • Chemotherapy
  • Pharmacokinetics
  • Hepatic Dysfunction
  • Neoplasms
  • Neoplasm Metastasis
  • Liver Diseases
  • Hepatic Insufficiency



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