| ID | Type | Description | Link |
|---|---|---|---|
| ET743-USA-1 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
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The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.
Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients 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. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabectedin | Experimental | Trabectedin 1.3 mg/m2 administered intravenously every 21 days. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabectedin | Drug | Trabectedin 1.3 mg/m2 administered intravenously every 21 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with objective response | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to approximately 3 years | |
| The number of patients with adverse events | Up to approximately 3 years | |
| Time to progression (TTP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
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| Label | URL |
|---|---|
| McMeekin DS, Lisyanskaya A, Crispens M, et al. Single-agent trabectedin as second-line therapy of persistent or recurrent endometrial cancer: results of a multi-center phase II study. Gynecol Oncol. 2009;114(2):288-92. | View source |
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| Dexamethasone |
| Drug |
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 |
|
| Up to approximately 3 years |
| Progression free survival (PFS), | Up to approximately 3 years |
| Miami |
| Florida |
| United States |
| Lexington | Kentucky | United States |
| Baltimore | Maryland | United States |
| New York | New York | United States |
| Oklahoma City | Oklahoma | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Toronto | Ontario | Canada |
| Maastricht | Netherlands |
| Moscow | Russia |
| Obninsk | Russia |
| Saint Petersburg | Russia |
| Saint | Russia |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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