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NCT01869400: NIS-OvaYond
An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
trial in Recurrent Ovarian Cancer in 83 participants. Completed in 1 February 2017.
1 December 2016
Quick facts
| Lead sponsor | PharmaMar, Spain |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 83 |
| Start date | 1 April 2013 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 February 2017 |
| Sites | 2 locations across Germany |
Conditions studied
- Recurrent Ovarian Cancer — all drugs for Recurrent Ovarian Cancer →
Sponsor
PharmaMar, Spain
Who can join
18 and older, female only, with Recurrent Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
safety and tolerability data of the study therapy
Time frame: during Yondelis-PLD-therapy
Number of patients with adverse events
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study.
Runnebaum IB, Reichert D, Ringsdorf U, Kuther M, et al · · 2018 · cited 6× · PMID 29623421 · DOI 10.1007/s00432-018-2637-1 -
Combinational use of trabectedin and pegylated liposomal doxorubicin for recurrent ovarian cancer: a meta-analysis of phase III randomized controlled trials.
Li C, Qiao S, Kang M, Gao X, et al · · 2023 · cited 3× · PMID 38186978
Verify or expand the search:
- PubMed search for NCT01869400
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Recurrent Ovarian Cancer
Currently open trials in the same condition.
- NCT06769425 — HS-10502 Combination Treatment in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07495384 — Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Pro · NA · recruiting
- NCT06560112 — An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer · Phase 2 · recruiting
- NCT05610735 — Combination Therapy for Recurrent Ovarian Cancer · Phase 1, PHASE2 · recruiting
- NCT06107868 — Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer · Phase 1 · active not recruiting
Other PharmaMar, Spain trials
Trials by the same sponsor.
- NCT02367924 — Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01869400 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PharmaMar, Spain
- Last refreshed: 4 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01869400.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing