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

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