Trial information
A Study of Once Weekly Versus Thrice Weekly NeoRecormon (Epoetin Beta) Therapy in Anemic Patients With Metastatic Solid Tumors Receiving Chemotherapy.
Status: Terminated
Protocol number: BH20198
Sponsor: F. Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: Open label, randomized, multicenter study to investigate the efficacy and safety of once-weekly (reduced administration frequency) NeoRecormon® (epoetin beta) therapy versus thrice weekly NeoRecormon® therapy in anemic patients with metastatic solid tumors receiving chemotherapy (or scheduled to re
Brief summary: This study will compare the efficacy and safety of once weekly and thrice weekly NeoRecormon in anemic patients with metastatic solid tumors who are receiving (or are scheduled to receive) chemotherapy for at least 9 weeks. Patients will be randomized to receive NeoRecormon either 30,000 IU s.c. once weekly, or 10,000 IU s.c. thrice weekly. The dose of NeoRecormon may subsequently be adjusted. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 280.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Hb AUC from study day 28 to week 12.
Key secondary outcomes: 1. Efficacy: Hb AUC from day 28 to week 12, % pts. with Hb rise >=1g/dL,with Hb rise >=2g/dL and % pts. who reach Hb 12-13g/dL; % pts. and time to hematopoietic response; RBC transfusion. Safety: AEs, thrombovascular events, laboratory tests, vital signs.
Inclusion criteria:
- adult patients, >=18 years of age;
- metastatic solid tumors, stage IV;
- receiving (or scheduled to receive) chemotherapy for >=9 weeks;
- Hb<=11g/dL.
Exclusion criteria:
- transfusion of RBC during 4 weeks prior to first dose of study medication;
- prior diagnosis of hematologic malignancies;
- history of thrombovascular event during 4 weeks prior to first dose of study medication;
- uncontrolled hypertension;
- acute or chronic bleeding (requiring therapy) within 3 months of start of study medication.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/17/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Czech Republic
- Nova Ves Pod Plesi
- Praha
- Tabor
Estonia
Germany
- Berlin
- Essen
- Hamburg
- Regensburg
- Stuttgart
Hungary
Latvia
Ukraine
- Dnipropetrovs'K
- Donetsk
- Kiev
- Lvov
- Uzhgorod
