Trial information
A Study of NeoRecormon(Epoetin Beta)in Anemic Patients With Solid Tumors
Status: Completed
Protocol number: ML17249
Sponsor: N.V. Roche S.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to assess the safety and effect on hemoglobin levels of NeoRecormon in anemic adult patients with solid tumors treated with non-platinum containing chemotherapy
Brief summary: This study will evaluate the safety and efficacy of NeoRecormon (30,000IU sc, administered once weekly for 12 weeks by pre-filled syringe)in adult, anemic patients with solid tumors, treated with non-platinum containing chemotherapy.The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals. Target sample size is 200.
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. Safety: adverse event rate and profile
Key secondary outcomes: 1. Efficacy: % patients with Hb increased >=1g/dL at week 4; % response at week 12; time to response; % patients with controlled Hb at week 12;need for transfusion and no. of Hb units transfused.
Inclusion criteria:
- adult patients,=18 years of age;
- solid tumors;
- treatment with non-platinum containing chemotherapy;
- anemia.
Exclusion criteria:
- red blood cell transfusion during the 2 months prior to start of study;
- 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: 03/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Bonheiden
- Brugge
- Bruxelles
- Charleroi
- Dendermonde
- Namur
- Oostende
- Roeselare
- Sint-Niklaas
- Tournai
- Verviers
- Vilvoorde
- Wilrijk
