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A Study of Trabectedin in Patients With Advanced Ovarian Cancer

NCT00050414 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2013-01-10

No results posted yet for this study

Summary

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.

Conditions

  • Ovarian Neoplasms
  • Endocrine Gland Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Ovarian Diseases
  • Adnexal Diseases
  • Genital Diseases, Female

Interventions

DRUG

Trabectedin

Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.

DRUG

Dexamethasone

Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Completion
2005-09-30

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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 NCT00050414 on ClinicalTrials.gov