A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554942

ML17912

Details and patient eligibility

About

This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults at least 18 years of age
• Presence of solid tumor(s)
• Receiving platinum-based therapy capable of inducing anemia

Exclusion criteria

• Red blood cell transfusion within 7 days prior to study drug
• Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug
• Women who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Epoetin beta

Experimental group

Description:

Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram \[IU/kg\]) for 16 weeks.

Treatment:

Drug: Epoetin beta