Trial information
A Study to Evaluate NeoRecormon (Epoetin Beta) in Anemic Patients With Solid Tumors Receiving Chemotherapy
Status: Terminated
Protocol number: ML17777
Sponsor: Roche (Hellas) SA
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety of NeoRecormon in patients with anemia and non-myeloid malignancies receiving chemotherapy
Brief summary: This study will evaluate the safety of subcutaneous NeoRecormon in anemic patients with non-myeloid malignancies (ie solid tumors) receiving chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 45.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Safety: Adverse event rate and profile
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients >=18 years of age;
- non-myeloid malignancy (ie solid tumors);
- anemia;
- chemotherapy scheduled for >=3 months from the time of first study treatment.
Exclusion criteria:
- blood transfusion within 2 months of study entry;
- erythropoietin treatment within 6 months of study entry;
- poorly controlled hypertension;
- relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Greece
- Athens
- Piraeus
- Thessaloniki
