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Completed

NCT Number: NCT02554942

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcoy, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

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.

Other names: NeoRecormon

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Hemoglobin response rate index

    Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 18, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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