Clinical trial · Observational
An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
- 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)
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population. Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials. This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.
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 |
|---|---|---|---|
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Yondelis-Pegylated liposomal Doxorubicin
- description
- 30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks
Primary outcomes (1)
- measure
- safety and tolerability data of the study therapy
- timeFrame
- during Yondelis-PLD-therapy
- description
- Number of patients with adverse events
Secondary outcomes (6)
- measure
- "Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
- timeFrame
- till one year after last date of Yondelis-PLD-therapy
- description
- Number of patients with CR, PR, SD as best response
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women age \>18, no upper limit * Patients with relapsed platinum-sensitive ovarian cancer * Before inclusion in the NIS written informed consent must be given Exclusion Criteria: * According to summary of product characteristics
References
Publications (0)
Data not yet available