Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Solid Tumors
Status: Completed
Protocol number: ML17435
Sponsor: Roche S.p.a.
Company division: Pharmaceutical
Official Scientific Title: An open-label pilot study of NeoRecormon on hemoglobin level/correction in patients with anemia and solid tumors.
Brief summary: This study will evaluate the efficacy and safety of subcutaneous NeoRecormon in patients with anemia and solid tumors. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 150.
Study phase: III
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. Percent of patients with increase in hemoglobin of >1 g/dL.
Key secondary outcomes: 1. Time between beginning of treatment and increase in hemoglobin of >1 g/dL; percent of patients with early response at end of Week 2 and for absence of response at end of Week 4; transfusion needs; quality of life; and tolerability.
Inclusion criteria:
- adult patients >18 years of age;
- confirmed tumor diagnosis;
- anemia;
- first or second lines of chemotherapy.
Exclusion criteria:
- relevant acute or chronic bleeding;
- thalassemic syndrome;
- 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: 08/29/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bari
- Benevento
- Cagliari
- Campobasso
- Napoli
- Palermo
