Darbepoetin Alfa With or Without Intravenous (IV) Iron

NCT00401544 | Completed Phase 2 Results

• 1 other identifier: 20060103
• Study Type: interventional
• Target: 243
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Anemia; Non-Myeloid Malignancies

Keywords

anemia; chemotherapy induced anemia; darbepoetin alfa; cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose

  Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.

  From Week 1 to Week 16

• Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage

  Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.

  From Week 1 to Week 16

Secondary Outcomes (13)

• Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose

  From Week 1 to Week 16

• Time to Achieve the Target Hemoglobin Level, by IV Iron Usage

  From Week 1 to Week 16

• Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose

  Baseline and Week 16

• Change From Baseline in Hemoglobin Concentration, by IV Iron Usage

  Baseline and Week 16

• Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose

  From Week 1 to Week 16

Study Arms (4)

Darbepoetin alfa 300 μg plus IV Iron

EXPERIMENTAL

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).

Drug: darbepoetin alfa; Drug: IV iron dextran

Darbepoetin alfa 300 μg

EXPERIMENTAL

Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Drug: darbepoetin alfa

Darbepoetin alfa 500 μg

EXPERIMENTAL

Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Drug: darbepoetin alfa

Darbepoetin alfa 500 μg plus IV Iron

ACTIVE COMPARATOR

Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Drug: darbepoetin alfa; Drug: IV iron dextran

Interventions

darbepoetin alfa DRUG

Darbepoetin alfa administered by subcutaneous injection.

Also known as: Aranesp®

Darbepoetin alfa 300 μg; Darbepoetin alfa 300 μg plus IV Iron; Darbepoetin alfa 500 μg; Darbepoetin alfa 500 μg plus IV Iron

IV iron dextran DRUG

Administered by intravenous (IV) injection.

Also known as: INFeD®, Cosmofer®

Darbepoetin alfa 300 μg plus IV Iron; Darbepoetin alfa 500 μg plus IV Iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Auerbach 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 RESULT

Related Links

• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Darbepoetin alfa; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 20, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: January 29, 2014
• Results First Posted: January 29, 2014

Record last verified: 2013-12