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

Janssen Research & Development, LLC15 enrolled

Overview

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.

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 dysfunction (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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm Metastases Hepatic Insufficiency

Interventions

TrabectedinDRUG

Trabectedin 0.58 or 1.3 mg/m\^2 (or adjusted dose) i.v. will be administered on Day 1.

DexamethasoneDRUG

Dexamethasone will be administered as 20 mg/m\^2, 30 minutes prior to trabectedin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Locations (11)

Unnamed facility

Scottsdale, Arizona, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

New York, New York, United States

Unnamed facility

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Pharmacokinetics of trabectedin

Time frame: At protocol-specified time points for up to 8 days

Secondary Outcomes

Number of patients with adverse events

Time frame: Up to 30 days after the administration of trabectedin

Findings from clinical laboratory evaluations

Time frame: Up to 30 days after the administration of trabectedin

Findings from vital signs measurements

Time frame: Up to 30 days after the administration of trabectedin

Findings from physical examinations

Time frame: Up to 30 days after the administration of trabectedin

Evaluate survival data

Time frame: at a time point to be determined by the sponsor at a later date.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.