Trial information
A Study of NeoRecormon (Epoetin Beta) in the Treatment of Anemia in Patients Receiving Chemotherapy
Status: Completed
Protocol number: ML17617
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: An open-label study of NeoRecormon on anemia correction in patients with anemia who have non-myeloid malignancies and are receiving chemotherapy
Brief summary: This study will evaluate the efficacy and tolerability of NeoRecormon in treating anemia in patients with nonmyeloid malignancies who are receiving chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is
700.
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: Hematological response
Key secondary outcomes: 1. Documentation of transfusions; time to hemoglobin response and median increase in hemoglobin; safety: adverse events, vital signs, laboratory parameters; cognitive function: HADS score, digit span from WAIS-R, and digit symbol test
Inclusion criteria:
- adult patients >=18 years of age;
- nonmyeloid malignancy;
- anemia;
- scheduled to start chemotherapy; or, for those already receiving chemotherapy, >=12 additional weeks of chemotherapy.
Exclusion criteria:
- acute lymphoblastic leukemia or brain metastasis;
- scheduled brain radiotherapy;
- scheduled high-dose chemotherapy with bone marrow or stem cell transplantation;
- erythropoiesis-stimulating therapy within past 2 months.
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
- Aix en Provence
- Ales
- Amiens
- Angers
- Angouleme
- Annecy
- Aulnay Sous Bois
- Avignon
- Bayonne
- Beauvais
- Blois
- Bobigny
- Bordeaux
- Bourg En Bresse
- Brive
- Caen
- Chalon Sur Saone
- Chambery
- Clermont-Ferrand
- Colmar
- Creteil
- Dijon
- Grenoble
- Hyeres
- Le Chesnay
- Le Mans
- Lens
- Lille
- Limoges
- Lyon
- Marseille
- Martigues
- Metz
- Montelimar
- Montpellier
- Nantes
- Nice
- Nimes
- Orleans
- Paris
- Perpignan
- Pessac
- Pierre Benite
- Poitiers
- Quimper
- Rennes
- Saint Brieuc
- Saint Quentin
- Saint-Cloud
- Saint-Michel
- Saint-Priest-En-Jarez
- Strasbourg
- Toulon
- Toulouse
- Tours
- Vandoeuvre-Les-Nancy
