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

Cancer Clinical Trial

Official title:

Flexibility: A Study to Assess the Impact of Once Per Cycle Correction and Maintenance Dosing of Darbepoetin Alfa in Subjects With Non-Myeloid Malignancies With Anemia Due to Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144131
• Other study ID #: 20040262
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: May 22, 2013
• Start date: August 2005

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Cancer

Intervention

Drug:
• Aranesp®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin (Hb) in chemotherapy induced anemia
Secondary	Patient-reported outcomes including overall health, fatigue, and daily activities

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling