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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554942
• Other study ID #: ML17912
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2015
• Last updated: November 1, 2016
• Start date: June 2004
• Est. completion date: September 2005

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: Spain
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 16 weeks	No
Secondary	Hemoglobin response rate index		Up to 16 weeks	No