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

Completed · Phase 2

Conditions studied: Endometrial Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female Urogenital Neoplasms

In brief

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

Key facts

Study ID

NCT00050440

Run by

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

People needed

50

Starts

2002-07-01

Expected to finish

2004-07-01

Last updated by the study team

2013-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of advanced or metastatic endometrial carcinoma
• Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
• At least one measureable tumor lesion
• Adequate bone marrow, hepatic and renal function
• Performance status ECOG 0 or 1

You may not qualify if…

• Prior exposure to trabectedin
• Known hypersensitivity to dexamethasone or to any of the components of trabectedin
• Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
• History of another neoplastic disease unless in remission for more than 5 years
• Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
• Current pregnancy, lactation, or childbearing potential without adequate method of contraception.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Miami, Florida, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — New York, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Toronto, Ontario, Canada
• Study site — Maastricht, Netherlands
• Study site — Moscow, Russia
• Study site — Obninsk, Russia
• Study site — Saint Petersburg, Russia
• Study site — Saint, Russia

Full record on ClinicalTrials.gov

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