Clinical trial · Interventional
A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy
Pilot Study for Evaluating the Efficacy and Tolerability of Induction Therapy With Recombinant Human Erythropoietin Beta (rHuEPO) NeoRecormon® - at High Dose in Anemic Cancer Patients Treated With Chemotherapy
NCT02767765CI-TRIAL-00026766completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| r-HuEPO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- r-HuEPO
- description
- Anemic cancer participants will receive r-HuEPO for 4 weeks.
- interventionNames
- Drug: r-HuEPO
Primary outcomes (1)
- measure
- Percentage of Participants With Response to Treatment
- timeFrame
- Week 4
- description
- 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 outcomes (5)
- measure
- Time to Response
- timeFrame
- Baseline up to Week 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.