Clinical trial · Interventional
A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy
A Randomized, Open-Label, Comparative Study of Epoetin Alfa (PROCRIT) 80,000 Units or 120,000 Units Q3W (Every 3 Weeks) Versus Darbepoetin Alfa (ARANESP) 500 Mcg Q3W in Anemic Cancer Subjects Receiving Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No safety signals were noted. The study was stopped because it was no longer consistent with the company's scientific and strategic focus.
Summary
Brief summary (as posted)
The purpose of this study is to compare hemoglobin response rates between two PROCRIT (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving chemotherapy
Conditions
Conditions (3)
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 | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| darbepoetin alfa | Drug | — | UNRESOLVED |
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- epoetin alfa (120,000 Units)
- description
- epoetin alfa (PROCRIT) 120,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks
- interventionNames
- Drug: epoetin alfa
- type
- EXPERIMENTAL
- label
- epoetin alfa (80,000 Units)
- description
- epoetin alfa (PROCRIT) 80,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks
- interventionNames
- Drug: epoetin alfa
- type
- ACTIVE_COMPARATOR
- label
- darbepoetin alfa (500 mcg)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of a non-myeloid malignancy * Baseline hemoglobin (Hb) value of \<= 11.0 g/dL unrelated to transfusion * No Packed Red Blood Cell (PRBC) or platelet transfusions in the 28 days prior to randomization * Scheduled to receive chemotherapy for a minimum of 12 weeks during the study * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 Exclusion Criteria: * No planned non-palliative radiation during the study * No current anemia due to factors other than cancer/chemotherapy (eg, iron deficiency or gastrointestinal bleeding) * No uncontrolled hypertension (defined as systolic pressure \> 180 and/or a diastolic pressure \> 100 mmHg while receiving antihypertension therapy) * No history of Deep Venous Thrombosis (DVT) or Pulmonary Embolus (PE) within 12 months before study enrollment. Prior superficial thrombophlebitis is not an exclusion criterion * No history of Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Acute Coronary Syndrome (ACS) including unstable angina and myocardial infarction with or without ST elevation, or other arterial thrombosis within 6 months before study enrollment
References
Publications (0)
Data not yet available