Anaemia in breast tumour subjects
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: epoetin beta
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 10,000-
Pharmaceutical Form:
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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 170 mm Hg or diastolic blood pressure = 100 mm Hg) • Platelet count 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) ;Secondary Objective: • Percentage of patients achieving target Haemoglobin (Hb) (12-13 g/dL) response • To compare the time to reach the target Hb level of 12-13 g/dL • To compare the safety of NeoRecormon® administered 30,000 IU q1w sc with NeoRecormon® administered 10,000 IU sc tiw ;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) | — |
Countries
Austria, Czech Republic, Estonia, Germany, Hungary, Latvia, United Kingdom
Outcome results
None listed