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

Roche

Status and phase: Terminated; Phase 4

Conditions: Anemia

Treatments: Drug: Epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02624141

ML18054

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Epoetin Beta 30000 IU

Experimental group

Description:

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.

Treatment:

Drug: Epoetin Beta