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 anemic patients with metastatic solid tumors receiving chemotherapy (or scheduled to receive chemotherapy)
- Conditions
- Anaemia in breast tumour subjects
- Registration Number
- EUCTR2006-002119-28-HU
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
•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 > 3 months
•WHO performance status grade 0-2
•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 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
- Primary Outcome Measures
Name Time Method Main Objective: •To demonstrate that epoetin beta (NeoRecormon®) administered 30,000 IU once weekly (q1w) subcutaneously (sc) is at least as efficacious as epoetin beta (NeoRecormon®) administered 10,000 IU sc thrice weekly (tiw) <br><br>;Secondary Objective: •Percentage of patients achieving target Haemoglobin (Hb) (12-13 g/dL) response <br>•To compare the time to reach the target Hb level of 12-13 g/dL <br>•To compare the safety of NeoRecormon® administered 30,000 IU q1w sc with NeoRecormon® administered 10,000 IU sc tiw<br>;Primary end point(s): Non-inferiority of NeoRecormon® once weekly versus thrice weekly analyzed by Hb Area Under Curve (AUC) from week 5 to week 12 (time- and baseline adjusted)<br>
- Secondary Outcome Measures
Name Time Method