Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Anemia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110955
• Other study ID #: 20030232
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2005
• Last updated: January 14, 2010
• Start date: February 2004
• Est. completion date: April 2005

Study information

• Verified date: January 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: April 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with non-myeloid malignancy

• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule

• Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization

• Adequate serum folate and vitamin B12

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Of legal age at the time written informed consent is obtained

Exclusion Criteria:

• Known history of seizure disorder

• Known primary hematologic disorder causing anemia other than non-myeloid malignancies

• Unstable/uncontrolled cardiac condition

• Clinically significant inflammatory disease

• Other diagnoses not related to the cancer which can cause anemia

• Inadequate renal and liver function

• Iron deficiency

• Known positive test for HIV infection

• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO

• Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1

• Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1

• Other investigational procedures

• Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)

• Pregnant or breast feeding

• Not using adequate contraceptive precautions

• Previously randomized into this study

• Known hypersensitivity to any products to be administered

• Concerns for subject's compliance

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms
• Non-Myeloid Malignancies

Intervention

Drug:
• Darbepoetin alfa
Q3W 300 mcg darbepoetin alfa
• Placebo
Q3W dosing of placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)		from week 5 to EOTP	No
Secondary	Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP		from week 5 to EOTP	No
Secondary	Number of RBC transfusions from week 5 to EOTP		from week 5 to EOTP	No
Secondary	Change in FACT-Fatigue subscale score from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in FACT-G Physical Well-being subscale from baseline to EOTP		from baseline to EOTP	No
Secondary	Incidence and severity of adverse events		throughout study	Yes
Secondary	Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study		at any time on study	Yes
Secondary	Change in FACT-G total score from baseline to EOTP		from baseline to EOTP	No
Secondary	Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences		throughout study	Yes
Secondary	Change in EQ-5D Thermometer from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in BSI Anxiety scale score from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in BSI Depression scale score from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in number of caregiver hours from baseline to EOTP		from baseline to EOTP	No
Secondary	Incidence of a confirmed antibody formation to darbepoetin alfa		throughout study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling