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

An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02554942

Enrollment

Registered

2015-09-18

Start date

2004-06-30

Completion date

2005-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief summary

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.

Interventions

DRUGEpoetin beta

Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	Up to 16 weeks

Secondary

Measure	Time frame
Hemoglobin response rate index	Up to 16 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026