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Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

NCT00050440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-01-08

No results posted yet for this study

Summary

The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Conditions

  • Endometrial Neoplasms
  • Uterine Neoplasms
  • Genital Neoplasms, Female Urogenital Neoplasms

Interventions

DRUG

Trabectedin

Trabectedin 1.3 mg/m2 administered intravenously every 21 days.

DRUG

Dexamethasone

Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose

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
2002-07-31
Completion
2004-07-31

Countries

  • United States
  • Canada
  • Netherlands
  • Russia

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 NCT00050440 on ClinicalTrials.gov