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

February 12, 2016 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trabectedin 1.3 mg/m^2 plus Dexamethasone
Control group Trabectedin 1.3 mg/m^2 i.v.will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
Drug: Trabectedin
Trabectedin 0.58 or 1.3 mg/m^2 (or adjusted dose) i.v. will be administered on Day 1.
Drug: Dexamethasone
Dexamethasone will be administered as 20 mg/m^2, 30 minutes prior to trabectedin.
Experimental: Trabectedin 0.58 mg/m^2 plus Dexamethasone
Hepatic dysfunction group Trabectedin 0.58 mg/m^2 (or adjusted dose) i.v. will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
Drug: Trabectedin
Trabectedin 0.58 or 1.3 mg/m^2 (or adjusted dose) i.v. will be administered on Day 1.
Drug: Dexamethasone
Dexamethasone will be administered as 20 mg/m^2, 30 minutes prior to trabectedin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of trabectedin
Time Frame: At protocol-specified time points for up to 8 days
At protocol-specified time points for up to 8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: Up to 30 days after the administration of trabectedin
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
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
Up to 30 days after the administration of trabectedin
Findings from physical examinations
Time Frame: Up to 30 days after the administration of trabectedin
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.
at a time point to be determined by the sponsor at a later date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

PharmaMar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017542
  • ET7430OVC1004 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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