Open label, randomized, multicenter study to investigate the efficacy and safety of once-weekly (reduced administration frequency) NeoRecormon® (epoetin beta) therapy versus thrice weekly NeoRecormon® therapy in anaemic patients with metastatic solid tumours receiving chemotherapy (or scheduled to receive chemotherapy)

• Conditions: Aneamic patients with metastatic solid tumours receiving chemotherapy or scheduled to receive chemotherapy.; MedDRA version: 8.1Level: LLTClassification code 10002034Term: Anaemia

• Registration Number: EUCTR2006-002119-28-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

•Adults (age = 18 years) with cytologically or histologically confirmed diagnosis of metastatic solid tumors, stage IV (breast, lung, colorectal, ovarian, cervical and prostate cancer) receiving chemotherapy (or scheduled to receive chemotherapy) for at least 9 weeks.
•Hb < 11 g/dL (110 g/L) at screening visit
•Life expectancy > 6 months
•WHO performance status grade 0-1
•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 RBC during the 4 weeks (28 days) prior to the first planned dose of study medication
•Concomitant radiometabolic therapy (e.g. strontium)
•Prior diagnosis of haematologic malignancies eg. lymphoma, lymphoproliferative diseases, Hodgkin’s diseases, chronic lymphocytic leukaemia, acute leukaemia, myelodysplastic syndromes, myeloproliferative syndromes
•Patients who have experienced thrombovascular event within 28 days preceding the first dose of study medication
•Patients with brain metastases or history of brain metastases
•Iron deficiency defined as transferrin saturation <20% which can not be treated with iron supplementation prior to start of study treatment.
•Uncontrolled hypertension (sitting systolic blood pressure > 170 mm Hg or diastolic blood pressure = 100 mm Hg)
•Platelet count< 50 or > 450 x 10 000 000 000/L (screening visit)
•Known uncorrected vitamin B12 or folic acid deficiency
•Prior diagnosis of primary red cell disorders which cause anemia [i.e., hemoglobinopathy, pure red cell aplasia (PRCA)]
•Patients with acute infection
•Patients with known hemolysis
•Epilepsy
•Pregnancy or breast feeding
•Any erythropoiesis stimulating agents (ESA) including NeoRecormon® administered during the period beginning 28 days preceding the first dose of study medication
•Any investigational drug administered during the period beginning 28 days preceding the first dose of study medication
•Known resistance to other ESAs
•Known hypersensitivity to any of the inactive substance or an active ingredient of NeoRecormon® or other ESAs
•Acute or chronic bleeding requiring therapy within 3 months prior to planned start of study medication (e.g. patients with anemia caused by gastrointestinal bleeding)

Study & Design

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