Phase 3
Completed N=61
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy
Source: ClinicalTrials.gov NCT02767765 ↗Enrolled (actual)
61
Serious AEs
4.9%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants With Response to Treatment — 50.8 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Response to Treatment |
50.8 | — |
| SECONDARY Time to Response |
19 | — |
| SECONDARY Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment |
78.7 | — |
| SECONDARY Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment |
50.8 | — |
| SECONDARY Percentage of Participants Who Required Transfusion |
8.2; 4.9; 1.7 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4 |
23.59; -6.23 | — |
Eligibility Criteria
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 r-HuEPO
- Insufficient controllable hypertension
- Thalassemic syndromes
- Anemia caused by hematic loss
- Women who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02767765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.