A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy

Anemia Clinical Trial

Official title:

Pilot Study for Evaluating the Efficacy and Tolerability of Induction Therapy With Recombinant Human Erythropoietin Beta (r-HuEPO) NeoRecormon® - at High Dose in Anemic Cancer Patients Treated With Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767765
• Other study ID #: ML17435
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2016
• Last updated: May 9, 2016
• Start date: June 2003
• Est. completion date: October 2006

Study information

• Verified date: May 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA-Agenzia Italiana del Farmaco, Ufficio Ricerca e Sperimentazione Clinica
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological or cytological confirmed cancer

• Participants who are treated with at least first line chemotherapy

• Hemoglobin less than (<) 11 grams per deciliter (g/dL)

• Participants able to receive iron supplement, if necessary

Exclusion Criteria:

• History of hypersensitivity to active or inactive excipients of NeoRecormon

• Insufficient controllable hypertension

• Thalassemic syndromes

• Anemia caused by hematic loss

• Women who are pregnant or lactating

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:
• r-HuEPO
All participants will receive r-HuEPO 10000 International Units (IU) per day (IU/day) for 6 days/week from the first week to the end of the second week and 10000 IU/day for 3 days/week from the third week to the end of the fourth week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Response to Treatment (Increase in Hemoglobin [> 1 g/dL] from Baseline) After 4 Weeks of Study Treatment		Week 4	No
Secondary	Time to Response Defined as the Time From the Start of Treatment and the Increase in Hemoglobin Level >1 g/dL		Week 4	No
Secondary	Percentage of Participants with Response to Treatment After 2 Weeks of Study Treatment as Assessed by Hemoglobin, Soluble Transferrin, or Reticulocyte Levels		Week 2	No
Secondary	Percentage of Participants with Absence of Response to Treatment After 4 Weeks of Study Treatment as Assessed by Hemoglobin Levels		Week 4	No
Secondary	Percentage of Participants who Required Transfusion		Week 4	No
Secondary	Quality of life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score		Week 4	No
Secondary	Number of Participants with Adverse Events		4 weeks	No