An open-label, single arm, multicenter study to assess the safety and efficacy of once-weekly administration of NeoRecormon using the 30.000 IU prefilled syringe in anaemic adult patients with solid tumors treated with non-platinum containing chemotherapy - PANTHER

.V. Roche S.A.0 个研究点开始时间: 2005年11月24日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Adult (= 18 years) patients with solid tumors treated with non-platinum containing chemotherapy, which is scheduled for at least 12 weeks
•Haemoglobin <= 11 g/dL at visit 1
•WHO performance status grade 0-2
•Life expectancy > 6 months
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Transfusion of red blood cells during the 2 months prior to first planned dose of study medication
•Therapy-resistant hypertension (sitting systolic blood pressure = 170 mmHg and diastolic blood pressure = 110 mmHg)
•Known clinically relevant acute or chronic bleeding, i.e. requiring therapy within 3 months prior to planned start of study treatment, e.g. patient with anaemia caused by gastrointestinal bleeding
•Known vitamin B12 deficiency, e.g. erythrocyte MCV > 105 fL
•Known folic acid deficiency, e.g. erythrocyte MCV > 105 fL
•Known haemolysis: haptoglobin < 30mg/dL (3.54 µmol/L) or other reliable positive test of haemolysis
•Patients scheduled to receive bone marrow transplantation during the study treatment period
•Platelet count < 50 or > 450 x 109/L at visit 1
•Pregnancy or lactation period
•Any unregistered drug in the 30 days preceding the first dose of the study medication or during the study
•Patients who previously completed or prematurely withdrew from this study

发起方

.V. Roche S.A.