WHO ICTRP trial
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE III STUDY OF…
PER-087-11 · Registro Peruano de Ensayos Clínicos (REPEC)
Key facts
| Trial ID | PER-087-11 |
|---|---|
| Public title | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE III STUDY OF RAD001 ADJUVANT THERAPY IN POOR RISK PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) OF RAD001 VERSUS MATCHING PLACEBO AFTER PATIENTS HAVE ACHIEVED COMPLETE RESPONSE WITH FIRST-LINE RITUXIMAB-CHEMOTHERAPY |
| Scientific title | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE III STUDY OF RAD001 ADJUVANT THERAPY IN POOR RISK PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) OF RAD001 VERSUS MATCHING PLACEBO AFTER PATIENTS HAVE ACHIEVED COMPLETE RESPONSE WITH FIRST-LINE RITUXIMAB-CHEMOTHERAPY |
| Primary sponsor | NOVARTIS BIOSCIENSES PERU S.A., |
| Registry | Registro Peruano de Ensayos Clínicos (REPEC) |
| Study type | Interventional |
| Phase | III |
| Countries | China;Korea North;United Arab Emirates;Israel;Japan;Lebano;Singapore;Thailand;Turkey;Germany;Austria;Slovakia;Spain;France;Greece;Hungary;Egypt;Italy;Norway;Poland;Russian… |
| Interventions | SELECTION ASSESSMENT IS CARRIED OUT IN 8 WEEKS PRIOR TO THE FIRST STUDY DRUG DOSE (-55 DAY TO DAY 0). SEE TABLE 7-1 FOR DETAILS OF SELECTION PROCEDURES. IT IS REQUIRED A CENTRAL REVIEW OF TUMOR TISSUE PATHOLOGY (BLOCK / CUTS WITHOUT STAIN)… |
| Registration date | Nov 24, 2011 |
| Target size | 10 |
| 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: