Clinical Trial Result Information

Protocol number
ML18041

Title of Study
Open label, multicenter study to investigate the safety of once weekly NeoRecormon therapy in anemic patients with non-myeloid malignancy.

Sponsor
F. Hoffmann-La Roche Ltd

Company division
Pharmaceutical

Product name
NeoRecormon

Generic name
epoetin beta

Therapeutic area
Anemia

Clinical study summary
This was an open-label study in anemic patients with non-myeloid malignancy, to investigate the safety of once weekly treatment, for 16 weeks, with NeoRecormon 30000 IU, administered via a pre-filled syringe. After 4 weeks’ treatment, the frequency of injections could be increased to twice weekly.

Study center(s)
2 centres in Peru.

Phase of development
IV

Objectives
To assess the safety of once-weekly administration of NeoRecormon using the 30 000 IU pre-filled syringe in anemic patients with non-myeloid malignancy.

Methodology
After screening, eligible patients with non-myeloid malignancies received weekly subcutaneous injections of NeoRecormon 30000 IU via pre-filled syringe. In the case of blood transfusion during week 4, or an inadequate haemoglobin response, the frequency of injections was increased to twice weekly, after 4 weeks. Study treatment was planned for 16 weeks.

Number of patients (planned/analyzed)
10 planned; 10 treated.

Diagnosis and main criteria for inclusion
Adult patients with histologically confirmed diagnosis of non-myeloid malignancy at screening visit. Hemoglobin<=11g/dL (<=6.82mmol/L) at screening visit. WHO performance status grade 0-2. Life expectancy >6 months.

Test product, dose and mode of administration or test procedure
NeoRecormon (epoetin beta) 30000 IU pre-filled syringe. Starting dose: subcutaneous injection of 30000 IU NeoRecormon administered once weekly. If after 4 weeks of treatment: blood transfusion was necessary in the last week, or hemoglobin did not increase by at least 0.5 g/dL versus baseline, the frequency of injections was to be increased to 30000 IU twice weekly.

Duration of treatment
16 weeks.

Reference therapy, dose and mode of administration or reference procedure
N/A

Criteria for evaluation (efficacy, safety)
Adverse event rate and profile

Statistical methods
The main conclusions of this study were based on the results of the per-protocol analysis. A descriptive statistical analysis of all adverse events occurring during this study was performed.

Summary (efficacy, safety, other results)
A total of 15 AEs (all mild or moderate in intensity) were reported during the study. Nine of the AEs were serious, but none of the SAEs was related to treatment. The most frequently reported adverse events were fever neutropenia (3 cases) and pneumonia (2 cases). Three AEs (hypercalcemia, hypocalcemia and increased phosphate) were considered related to NeoRecormon treatment.

Conclusions
In conclusion, in this study NeoRecormon was shown to be safe and well-tolerated in anemic patients with non-myeloid malignancies.

Date of report
8/1/2006

Click here for the protocol registry listing of this trial.