WHO ICTRP trial
Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with Dose…
EUCTR2010-020325-40-FR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2010-020325-40-FR |
|---|---|
| Public title | Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with Dose Optimization of Two Different Schedules of Elisidepsin Trifluoroacetate (Irvalec®) as a Single Agent in Patients with Unresectable, Locally Advanced or Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer After Failure of One but not More than Two Prior Lines of Systemic Therapy - IMAGE |
| Scientific title | Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with Dose Optimization of Two Different Schedules of Elisidepsin Trifluoroacetate (Irvalec®) as a Single Agent in Patients with Unresectable, Locally Advanced or Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer After… |
| Primary sponsor | Pharma Mar, 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 | France;United Kingdom |
| Conditions | Locally Advanced or Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer MedDRA version: 12.1 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer |
| Interventions | Product Name: IRVALEC (elisidepsin trifluoroacetate) Product Code: PM02734 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: elisidepsin trifluoroacetate CAS Number: 915713-02-09 Current Sponsor… |
| Registration date | Jun 7, 2010 |
| Target size | 126 |
| Secondary IDs | PM2734-B-002-09 |
| 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
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: