Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Solid Tumors
Status: Completed
Protocol number: ML17912
Sponsor: Roche Farma SA
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety of NeoRecormon in patients with solid tumors being treated with platinum capable of inducing anemia
Brief summary: This study will evaluate the safety of subcutaneous NeoRecormon in adult patients with solid tumors being treated with platinum capable of inducing anemia. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 87.
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. Efficacy: Hemoglobin response rate index
Inclusion criteria:
- adult patients >=18 years of age;
- solid tumors;
- receiving platinum therapy capable of inducing anemia.
Exclusion criteria:
- red blood cell transfusion within 7 days of study drug;
- poorly controlled hypertension;
- relevant acute or chronic bleeding, ie, 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: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Alcoy
- Barcelona
- Caceres
- El Palmar Murcia
- La Laguna
- Salamanca
- Valencia
- Vizcaya
