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CompletedNCT00144131Updated May 24, 2013

Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy

A Phase 2 interventional study of Aranesp® in Anemia and Cancer, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.

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Conditions studied

  • Anemia
  • Cancer

Keywords

  • Chemotherapy, Anemia
  • Aranesp®, rHuEPO
  • Chemotherapy Induced Anemia
  • non-myeloid malignancy
  • Non-Myeloid Malignancies
  • Chemotherapy
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 750 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: - Subjects with active non-myeloid malignancy(ies) including lymphocytic leukemias - Receiving chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a QW, every other week (Q2W) or every three weeks (Q3W) schedule - Anemia due to cancer and/or chemotherapy (screening Hb less than 11.0 g/dL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Subjects with 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 (e.g., 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 - Known iron deficiency (to be considered iron deficient a subject must have both of the following: a saturated transferrin less than 15% and ferritin less than 10 ng/mL at screening) - Unstable angina, or uncontrolled cardiac arrhythmia - Hypertension (diastolic blood pressure greater than 100 mmHg) - Inadequate renal and/or liver function (e.g., creatinine greater than 2 X upper limit of normal (ULN) and/or transaminase greater than 5 X ULN) - History of pure red blood cell aplasia - Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status - Known positive antibody response to any erythropoietic agent - Subject has known sensitivity to any erythropoietic agents, the study drug, or its excipients to be administered during this study

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
750 participants

Interventions

  • DrugAranesp®
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What researchers measure

Primary outcomes

  1. Change in hemoglobin (Hb) in chemotherapy induced anemia

Secondary outcomes

  1. Patient-reported outcomes including overall health, fatigue, and daily activities

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Schwartzberg L, Burkes R, Mirtsching B, Rearden T, Silberstein P, Yee L, Inamoto A, Lillie T. Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial. BMC Cancer. 2010 Oct 25;10:581. doi: 10.1186/1471-2407-10-581. PubMed 20973982 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00144131
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 5, 2005
Start date
Aug 2005
Last update
May 24, 2013

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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