Clinical trial · Interventional

Darbepoetin Alfa With or Without Intravenous (IV) Iron

Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

NCT00401544CI-TRIAL-00013612completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle 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	—
Non-Myeloid Malignancies	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
darbepoetin alfa	Drug	—	UNRESOLVED
IV iron dextran	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Darbepoetin alfa 300 μg plus IV Iron
description
Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
interventionNames
1. Drug: darbepoetin alfa
2. Drug: IV iron dextran
type
EXPERIMENTAL
label
Darbepoetin alfa 300 μg
description
Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
interventionNames
1. Drug: darbepoetin alfa
type
EXPERIMENTAL
label
Darbepoetin alfa 500 μg

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Active non myeloid malignancy(cies) including lymphocytic leukemias
* Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy
* Anemia due to chemotherapy (screening Hgb \<or = 10.0 g/dL)
* at least 18 years of age at screening

Exclusion Criteria:

* Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)
* Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy
* Active bleeding
* Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)
* Active, unstable systemic or chronic infection
* Planned elective surgery during the study where significant blood loss is expected
* Unstable angina, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg)
* History of pure red cell aplasia (PRCA)
* History of deep venous thrombosis
* Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status
* Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening
* Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
* Currently receiving or planned to receive myeloablative radiation therapy
* Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study
* Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)
* Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
* Known sensitivity to iron administration
* Pregnant or breast feeding

References

Publications (1)

RESULTAuerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, Bridges K. Darbepoetin alfa 300 or 500 mug once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010 Sep;85(9):655-63. doi: 10.1002/ajh.21779. PMID 20661916