WHO ICTRP trial
A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study…
EUCTR2008-004967-21-FR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2008-004967-21-FR |
|---|---|
| Public title | A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram - n/a |
| Scientific title | A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram - n/a |
| Primary sponsor | Pharma Mar, S.A. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;Belgium |
| Conditions | - to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in subjects with advanced solid tumor malignancies when administered at a therapeutic dose. MedDRA version: 9.1 Level… |
| Interventions | Trade Name: Yondelis 0,25 mg powder for concentrate for solution for infusion Product Name: YONDELIS (Trabectedin) Product Code: ET-743 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Trabectedin… |
| Registration date | Oct 12, 2008 |
| Target size | 60 |
| Secondary IDs | ET743-OVC-1001;2008-004967-21-BE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: