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

NCT01273493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-02-15

No results posted yet for this study

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.

Conditions

  • Neoplasm Metastases
  • Hepatic Insufficiency

Interventions

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.

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Belgium
  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273493 on ClinicalTrials.gov