Clinical trial · Interventional
A Study of Trabectedin in Patients With Advanced Ovarian Cancer
Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
NCT00050414CI-TRIAL-00008858completedPhase 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 study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Diseases | — | UNRESOLVED | — |
| Endocrine Gland Neoplasms | — | UNRESOLVED | — |
| Genital Diseases, Female | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Ovarian Diseases | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian 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 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
- interventionNames
- Drug: Trabectedin
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Number of patients with objective response
- timeFrame
- Up to approximately 3 years
Secondary outcomes (8)
- measure
- The number of patients with an unbiased objective response
- 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 epithelial ovarian cancer * Progression or recurrence during or after platinum-containing regimen * At least one measureable tumor lesion * Adequate bone marrow, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: * Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone * Pregnant or lactating women * Known metastases (spread) of cancer to the central nervous system * History of another neoplastic disease unless in remission for five years or more.
References
Publications (0)
Data not yet available
No reference posted for this study.