Clinical trial · Interventional
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
NCT00115167CI-TRIAL-00002293completedPhase 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)
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
Conditions
Conditions (2)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa
- interventionNames
- Drug: Darbepoetin alfa
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- throughout study
Secondary outcomes (5)
- measure
- Confirmed antibody formation to investigational product
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol Exclusion Criteria: * Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy * Subjects who have other diagnoses not related to the cancer which can cause anemia * Known history of seizure disorder * Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment * Subject of reproductive potential who is not using adequate contraceptive precautions * Concerns for subject's compliance with the protocol procedures
References
Publications (1)
- DERIVEDSmith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28. PMID 18227526