Clinical trial · Interventional
Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma
A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
NCT00050440CI-TRIAL-00008829completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Genital Neoplasms, Female Urogenital Neoplasms | — | UNRESOLVED | — |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trabectedin
- description
- 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.
- interventionNames
- Drug: Trabectedin
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Number of patients with objective response
- timeFrame
- Up to approximately 3 years
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- Up to approximately 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.