Clinical trial · Observational
An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
NCT03446495CI-TRIAL-00031809RenaissanceunknownClinicalTrials.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)
This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trabectedin + PLD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trabectedin + PLD
- description
- Trabectedin + PLD according to SmPC
- interventionNames
- Drug: Trabectedin + PLD
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Patient will be followed during 37 weeks
- description
- ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).
Secondary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Patient will be followed during 37 weeks
- description
- PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>18 * Histologically proven epithelial ovarian cancer * ECOG 0-1 * Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months * With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication * Prior treatment with 1 or more chemotherapy regimen Exclusion Criteria: * Platinum resistant disease: PFI \< 6 months (progression within six months after first-line platinum-based chemotherapy) * Unwilling or unable to have a central venous catheter * Patients with hepatic impairment (Patients with elevated bilirubin) * Patients with renal impairment (Patients with serum creatinine \>1.5 mg/dL) * Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3) * Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex) * AIDS-related Kaposi's sarcoma * Lactation or pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.