Trial information
A Study of NeoRecormon (Epoetin Beta) for Prevention and Treatment of Anemia in Patients With Solid Tumors Receiving Platinum-Based Chemotherapy Prone to Induce Anemia
Status: Completed
Protocol number: ML17620
Sponsor: Shanghai Roche Pharmaceuticals Ltd.
Company division: Pharmaceutical
Official Scientific Title: Multicenter Open Label Study of NeoRecormon prevention and treatment for anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia
Brief summary: A study of the efficacy and safety of NeoRecormon in patients with solid tumors treated with platinum-based chemotherapy prone to induce anemia. Patients will be randomized to receive either NeoRecormon or standard treatment (blood transfusion and iron supplement) coinciding with the start of platinum-based chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 120.
Study phase: III
Study type: Interventional; Treatment; Open Label; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: percentage of patients with increase in hemoglobin values >=2g/dL without transfusion in the previous 6 weeks.
Key secondary outcomes: 1. Efficacy: Increase in hemoglobin; number and volume of blood transfusions; and levels of hematocrit, red blood cells, reticulocytes, and iron. Safety:adverse events, blood pressure and laboratory values.
Inclusion criteria:
- adult patients >=18 years of age;
- solid tumor verified by histologic examination;
- platinum-based chemotherapy (for >=3 months) planned.
Exclusion criteria:
- history of other malignancy;
- clinically relevant cardiovascular disease;
- acute or chronic bleeding within 3 months prior to start of study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/30/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Guangzhou
- Shanghai
- Shantou
- Wuhan
