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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002119-28-LV
• Date of registration: 24/08/2006
• Prospective Registration: No
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: Open label, randomized, parallel group, multicenter study to investigate the efficacy and safety of once-weekly (reduced administration frequency) NeoRecormon® therapy versus thrice weekly NeoRecormon® therapy in anaemic cancer patients with solid tumours receiving chemotherapy (or scheduled to receive chemotherapy)
• Scientific title: Open label, randomized, parallel group, multicenter study to investigate the efficacy and safety of once-weekly (reduced administration frequency) NeoRecormon® therapy versus thrice weekly NeoRecormon® therapy in anaemic cancer patients with solid tumours receiving chemotherapy (or scheduled to receive chemotherapy)
• Date of first enrolment: 21/07/2006
• Target sample size: 280
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002119-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: NeoRecormon® administered 10,000 IU thrice weekly

Countries of recruitment

Austria, Czech Republic, Estonia, Germany, Hungary, Latvia, United Kingdom

Key inclusion & exclusion 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 < 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

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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Anaemia in breast tumour subjects

Intervention(s)

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: Solution for injection
INN or Proposed INN: epoetin beta
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 20,000-

Pharmaceutical Form: Solution for injection
INN or Proposed INN: epoetin beta
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 30,000-

Primary Outcome(s)

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)

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)

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

Secondary ID(s)

2006-002119-28-HU

BH 20198