A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment

This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin Beta

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Venezuela
  • Caracas, Venezuela, 1060
  • Valencia, Venezuela, 2001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with a non-myeloid malignancy
• Anemia

Exclusion Criteria:

• Transfusion of red blood cells within 2 months of study drug
• Treatment-resistant hypertension
• Acute or chronic bleeding (requiring therapy) within 3 months of study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epoetin Beta 30000 IU; Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks.	Drug: Epoetin Beta; Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.; Other Names: Recormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin Levels at 16 Weeks	16 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Iron Levels	16 Weeks
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument	Up to 4 months
Tolerability - Incidence of Adverse Events	Up to 4 months
Serum Transferrin Levels	16 Weeks
Percentage of Participants With A Positive Response	16 Weeks
Time To Global Response	Up to 4 months
Quality of Life In Relation to Anemia Grade	Up to 4 months
Serum Ferritin Levels	16 Weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML18054