Multicenter open study to investigate the safety of weekly therapy with Neorecormon in anemic patients with malignant solid tumors.

Not Applicable

• Registration Number: PER-042-04
• Lead Sponsor: PRODUCTOS ROCHE Q.F.S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

* Adult patients diagnosed with solid malignant tumor with histological confirmation
* Hemoglobin <11 gr / dL (<6.82 mmot / L) at the screening visit.
* If antineoplastic therapy is to be administered, it must be scheduled for at least 4 months from the first dose of the study treatment.
* Performance status according to WHO grade 0-2.
* Life expectancy> 6 months
* Written informed consent.

Exclusion Criteria

* Transfusion of red blood cells during the 2 months prior to the first dose of the study medication.
* High blood pressure resistant to treatment.
* Relevant chronic or acute bleeding, which needed treatment within 3 months prior to the start of the study, example patient with anemia caused by gastrointestinal bleeding.
* Anti-tumor therapy in the week prior to the screening visit apart from corticosteroids
* Patients scheduled to receive bone marrow transplantation during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:clinic history<br>Measure:clinical evaluation of the efficacy of the drug<br>Timepoints:3 semanas<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Adverse effects and laboratory alterations<br>Measure:evaluation of the safety of the drug<br>Timepoints:3 weeks<br>