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

Anemia Clinical Trial

Official title:

Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564094
• Other study ID #: ML18043
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2015
• Last updated: November 1, 2016
• Start date: February 2005
• Est. completion date: June 2006

Study information

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

Clinical Trial Summary

This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults at least 18 years of age

• Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer

• Anemia with low erythropoeitin (EPO) levels

Exclusion Criteria:

• Poorly controlled hypertension

• Relevant acute or chronic bleeding requiring therapy within 3 months before study drug

• Treatment with EPO within the last 6 weeks

• Pregnant or breastfeeding females

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin beta
Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to hemoglobin level		At Week 4	No
Primary	Transfusion requirement rate		From Weeks 5 to 12	No
Primary	Predictive value of reticulocyte increase		At Week 2	No
Secondary	Incidence of adverse events (AEs)		Up to approximately 6 months	No