WHO ICTRP trial
RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL TO COMPARE THE EFFICACY OF IPILIMUMAB VS…
PER-048-10 · Registro Peruano de Ensayos Clínicos (REPEC) · Not Recruiting
Key facts
| Trial ID | PER-048-10 |
|---|---|
| Public title | RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL TO COMPARE THE EFFICACY OF IPILIMUMAB VS PLACEBO IN ASYMPTOMATIC OR MINIMALLY SYMPTOMATIC PATIENTS WITH METASTATIC CHEMOTHERAPY-NAÏVE CASTRATION RESISTANT PROSTATE CANCER |
| Scientific title | RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL TO COMPARE THE EFFICACY OF IPILIMUMAB VS PLACEBO IN ASYMPTOMATIC OR MINIMALLY SYMPTOMATIC PATIENTS WITH METASTATIC CHEMOTHERAPY-NAÏVE CASTRATION RESISTANT PROSTATE CANCER |
| Primary sponsor | BRISTOL MYERS SQUIBB COMPANY, |
| Registry | Registro Peruano de Ensayos Clínicos (REPEC) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | III |
| Countries | India;Turkey;Germany;Denmark;Spain;France;Greece;Netherlands;Italy;Norway;Poland;United Kindgdom;Romania;Russian Federation;Sweden;Australia;Hungaria;Czech… |
| Conditions | -C61 Malignant neoplasm of prostate Malignant neoplasm of prostate;C61 ;Malignant neoplasm of prostate |
| Interventions | Group name:Group 1 Type of group;1 N° of participants:400 Intervention(s) description:Ipilimumab 5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to… |
| Registration date | Mar 11, 2010 |
| Target size | 20 |
| Secondary IDs | NCT01057810 |
| Registry page | ins.gob.pe |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: