Detail of the clinical trial
| Title of the trial | A Phase 3, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in the adjuvant treatment of patients with Stage III or high-risk Stage II colorectal cancer |
|---|---|
| EudraCT number | 2017-004707-43 |
| Protocol number | PP06489 |
| Sponsor | PledPharma AB, Grev Turegatan 11c, SE 114 46 Stockholm, Sweden |
| Indications | Oncology |
| Diagnosis | colorectal cancer |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2018 |
| Date of approval by Institute (SÚKL) | 1.2.2019 |
| Date of approval by EC | |
| Date of initiation CT in ČR | 10.6.2019 |
| Date of ending CT in ČR | 2.10.2020 |
| Notice | |
| Sites |
Všeobecná fakultni nemocnice v Praze, Onkologická klinika,U nemocnice 449/2,Praha 2,128 08 Nemocnice Horovice, NH Hospital, a.s.,Onkologie, K Nemocnici 1106, Horovice,268 31 Nemocnice Rudolfa a Stefanie Benešov, a.s.,Onkologické oddělení,Machova 400, Benešov,256 01 Nemocnice České Budějovice, a.s., Onkologicke oddělení, B. Němcové 585/54, České Budějovice,370 01 (discontinued) Nemocnice Na Plesi s.r.o.,Institut onkologie a rehabilitace,Nova Ves pod Plesi 110,Nova Ves pod Plesi ,262 04 Nemocnice Na Bulovce,Ústav radiační onkologie,Budinova 67/2,Praha 8 - Liben,180 81 Thomayerova nemocnice,Onkologická klinika,Videňská 800,Praha 4,140 59 |
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