A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

Phase 4

Terminated

• Conditions: Anemia
• Interventions: Drug: Epoetin Beta

• Registration Number: NCT02624141
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units \[IU\]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult patients with a non-myeloid malignancy
• Anemia

Exclusion Criteria

• Transfusion of red blood cells within 2 months of study drug
• Treatment-resistant hypertension
• Acute or chronic bleeding (requiring therapy) within 3 months of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Beta 30000 IU	Epoetin Beta	Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks.

Primary Outcome Measures

Name	Time	Method
Hemoglobin Levels at 16 Weeks	16 Weeks

Secondary Outcome Measures

Name	Time	Method
Serum Iron Levels	16 Weeks
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument	Up to 4 months
Tolerability - Incidence of Adverse Events	Up to 4 months
Serum Transferrin Levels	16 Weeks
Percentage of Participants With A Positive Response	16 Weeks
Time To Global Response	Up to 4 months
Quality of Life In Relation to Anemia Grade	Up to 4 months
Serum Ferritin Levels	16 Weeks