Clinical trial · Interventional
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
NCT00628043CI-TRIAL-00002645completedPhase 3ClinicalTrials.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 is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin beta | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EPOCH
- interventionNames
- Drug: epoetin beta
- type
- PLACEBO_COMPARATOR
- label
- placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
- timeFrame
- 16 weeks
Secondary outcomes (3)
- measure
- Change in Hb
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Lung cancer or gynecologic cancer patients * Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration * 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL * 20 - 79 years old * Performance status: 0 - 2 * No iron deficiency anemia Exclusion Criteria: * Red blood cell transfusion within 4 weeks before treatment * Erythropoietin therapy within 8 weeks before treatment
References
Publications (0)
Data not yet available
No reference posted for this study.