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

NCT00050440CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

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

Enrollment

50

Start Date

2002-07-01

Study Type

INTERVENTIONAL

Official Title

A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma

Interventions

TrabectedinDexamethasone

Conditions

Endometrial NeoplasmsUterine NeoplasmsGenital NeoplasmsFemale Urogenital Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Outcome Measures

Primary Outcomes

Number of patients with objective response

Time frame: Up to approximately 3 years

Secondary Outcomes

Overall survival (OS)

Time frame: Up to approximately 3 years

The number of patients with adverse events

Time frame: Up to approximately 3 years

Time to progression (TTP)

Time frame: Up to approximately 3 years

Progression free survival (PFS),

Time frame: Up to approximately 3 years

Locations

Los Angeles, United States

Miami, United States

Lexington, United States

Baltimore, United States

New York, United States

Oklahoma City, United States

Nashville, United States

Dallas, United States

Toronto, Canada

Maastricht, Netherlands

Moscow, Russia

Obninsk, Russia

Saint Petersburg, Russia

Saint, Russia