Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
With
PharmaMar
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma