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

• Conditions: Anaemia in adult patients with solid tumors treated with non-platinum containing chemotherapy; MedDRA version: 8.1Level: PTClassification code 10049105

• Registration Number: EUCTR2005-004189-17-BE
• Lead Sponsor: .V. Roche S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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
•Epilepsy
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified