N/A
N=220
Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
Relapsed Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02825420 ↗Enrolled (actual)
220
Serious AEs
17.0%
Results posted
Oct 2021
Primary outcome: Primary: Progression-Free Survival — 9.46 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- trabectedin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- PharmaMar
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
9.46 | — |
| PRIMARY Progression Free Survival by Prior Antiangiogenic Treatment |
7.59; 12.45 | 0.007 sig |
| PRIMARY Progression Free Survival by BRCA1/2 Status |
9.23; 8.97 | 0.58 |
| PRIMARY Progression Free Survival by Platinum Sensitivity |
9.26; 9.46 | 0.62 |
| SECONDARY Best Tumor Response |
24; 57; 59; 62; 16 | — |
| SECONDARY Best Response by Prior Antiangiogenic Treatment |
46; 16; 32; 27; 27; 30 | 0.010 sig |
| SECONDARY Overall Survival |
23.56 | — |
| SECONDARY Overall Survival by Prior Antiangiogenic Treatment |
21.85; 26.28 | 0.048 sig |
| SECONDARY Overall Survival by BRCA1/2 Status |
23.56; 21.85 | 0.51 |
| SECONDARY Overall Survival by Platinum Sensitivity |
23.56; 26.05 | — |
| SECONDARY Change From Baseline to Best Post-baseline ECOG Performance Status Score |
24; 125; 14; 55 | — |
| SECONDARY Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment |
14; 10; 83; 42; 5; 9 | — |
Summary
Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug
Eligibility Criteria
Inclusion Criteria
- Women aged 18 years or older.
- Presence of platinum-sensitive relapsed ovarian cancer.
- Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.
- Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.
- Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02825420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.