A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: r-HuEPO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767765

ML17435

Details and patient eligibility

About

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological confirmed cancer
• Participants who are treated with at least first line chemotherapy
• Hemoglobin less than (<) 11 grams per deciliter (g/dL)
• Participants able to receive iron supplement, if necessary

Exclusion criteria

• History of hypersensitivity to active or inactive excipients of r-HuEPO
• Insufficient controllable hypertension
• Thalassemic syndromes
• Anemia caused by hematic loss
• Women who are pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

r-HuEPO

Experimental group

Description:

Anemic cancer participants will receive r-HuEPO for 4 weeks.

Treatment:

Drug: r-HuEPO