WHO ICTRP trial
"Estudio clínico de fase II, multicéntrico, abierto de trabectedina (Yondelis®)…
EUCTR2010-022968-13-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2010-022968-13-ES |
|---|---|
| Public title | "Estudio clínico de fase II, multicéntrico, abierto de trabectedina (Yondelis®) en pacientes con cáncer de mama avanzado, HER2 negativo, positivo para receptores hormonales, con sobreexpresión o subexpresión del gen xeroderma pigmentosum de clase G (XPG)". |
| Scientific title | "Estudio clínico de fase II, multicéntrico, abierto de trabectedina (Yondelis®) en pacientes con cáncer de mama avanzado, HER2 negativo, positivo para receptores hormonales, con sobreexpresión o subexpresión del gen xeroderma pigmentosum de clase G (XPG)". |
| Primary sponsor | PharmaMar S.A. Sociedad Unipersonal |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Belgium;Spain |
| Conditions | Cáncer de mama avanzado. MedDRA version: 13 Level: LLT Classification code 10006204 Term: Carcinoma de mama |
| Interventions | Trade Name: YONDELIS 0,25 mg polvo para concentrado para solución para perfusión Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: TRABECTEDINA Other descriptive name: TRABECTEDINA Concentration unit: mg… |
| Registration date | Jan 25, 2011 |
| Target size | 100 |
| Secondary IDs | ET-B-031-10;2010-022968-13-BE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: