WHO ICTRP trial
A randomized, Phase III study of Fotemustine versus the Combination of…
EUCTR2012-004301-27-IT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-004301-27-IT |
|---|---|
| Public title | A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis |
| Scientific title | A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis - NIBIT-M2 |
| Primary sponsor | FONDAZIONE NIBIT |
| 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Italy |
| Conditions | Subjects (men and women) 18 years old presenting with Stage IV melanoma with presence of brain metastasis MedDRA version: 14.1 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms… |
| Interventions | Product Name: Ipilimumab Product Code: BMS-734016 Pharmaceutical Form: Solution for infusion INN or Proposed INN: IPILIMUMAB CAS Number: 477202009 Current Sponsor code: BMS734016 Concentration unit: mg/ml milligram(s)/millilitre… |
| Registration date | Oct 30, 2012 |
| Target size | 160 |
| Secondary IDs | NIBIT-M2 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No 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: