Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Solid Tumors or Hematologic Malignancies
Status: No longer recruiting
Protocol number: ML18275
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study of NeoRecormon on haemoglobin level/correction and elimination of transfusion need in patients with anemia and solid tumors or hematologic malignancies
Brief summary: This study will evaluate the efficacy and safety of subcutaneous NeoRecormon in patients with hematologic malignancies or solid tumors. The anticipated time on study treatment is <3 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/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: Increase in hemoglobin of >=2g/dL with elimination of transfusion need.
Key secondary outcomes: 1. Adverse event frequency, rate and profile.
Inclusion criteria:
- adult patients >=18 years of age;
- hematologic malignancy or a solid tumor;
- anemia.
Exclusion criteria:
- red blood cell transfusion within 2 months of study drug;
- 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
Anticipated start date: March, 2005
Trial registration date: 10/28/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Morocco
