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Phase 2 Study of ET-743 in Subjects With Advanced Ovarian Cancer

This study has been completed.

Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00050414
  Purpose

This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced ovarian cancer. After a subject meets all entry criteria and signs informed consent she will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting this study.


Condition Intervention Phase
Ovarian Cancer
Drug: ET-743
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Ecteinascidin 743   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria
  • Female subjects 18 years of age or older
  • Diagnosis of advanced epithelial ovarian cancer
  • Progression or recurrence during or after platinum containing regimen
  • At least one measureable tumor lesion
  • Adequate bone marrow, hepatic and renal function
  • Performance status ECOG 0 or 1
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050414

Locations
United States, California
USC, Norris Comprehensive Cancer Center    
      Los Angeles, California, United States, 90089
United States, Connecticut
Hematology Oncology, P.C.    
      Stamford, Connecticut, United States, 06902
United States, Kentucky
Norton Hospitals, Inc., Louisville Oncology    
      Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology Oncology Specialists    
      New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Dana Farber Cancer Institute / Mass General Hospital    
      Boston, Massachusetts, United States, 02114
United States, Oklahoma
University of Oklahoma Health Science Center    
      Oklahoma City, Oklahoma, United States, 73104
United States, Texas
US Oncology, Dallas    
      Dallas, Texas, United States, 75204

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
  More Information


Study ID Numbers:   ET743-INT-11
First Received:   December 9, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00050414
Health Authority:   United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
ovarian cancer  
ovary  
cancer  

Study placed in the following topic categories:
Ecteinascidin 743
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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