EUCTR2006-002119-28-EEActive, not recruitingNot Applicable
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)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd.
- Enrollment
- 280
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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)
Investigators
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