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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: r-HuEPO

• Registration Number: NCT02767765
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Status Verified: 2017-02
• Results First Submitted: 2017-02-16
• Results First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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Exclusion Criteria

• History of hypersensitivity to active or inactive excipients of r-HuEPO
• Insufficient controllable hypertension
• Thalassemic syndromes
• Anemia caused by hematic loss
• Women who are pregnant or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
r-HuEPO	r-HuEPO	Anemic cancer participants will receive r-HuEPO for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Response to Treatment	Week 4	Response to treatment was defined as an increase of greater than (\>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4	Baseline, Week 4	FACT-An comprises of 4 subscales of 27-item (FACT-General scale \[FACT-G\]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188.
Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment	Week 2	Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes \>40000 per microliter or \>25% increase in soluble transferrin receptor or \>0.5 g/dL increase in hemoglobin level.
Time to Response	Baseline up to Week 4	Time to response was defined as the time between the start of treatment and the increase in hemoglobin level \>1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.
Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment	Week 4	"No Response" to treatment after 4 weeks was defined as meeting any of the following criteria: \<1 g/dL increase in hemoglobin level or hemoglobin level \<8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of \>1 g/dL but required transfusion then the participant is considered as Non- Responder.
Percentage of Participants Who Required Transfusion	Baseline, Week 2, Week 4