Clinical trial NCT00110955: Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Non-Myeloid Malignancies
Keywords: Non-myeloid malignancy
Chemotherapy-induced anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-17
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
timeFrame: from week 5 to EOTP
Secondary outcomes:
measure: 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
timeFrame: from week 5 to EOTP
measure: Number of RBC transfusions from week 5 to EOTP
timeFrame: from week 5 to EOTP
measure: Change in FACT-Fatigue subscale score from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Change in FACT-G Physical Well-being subscale from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Incidence and severity of adverse events
timeFrame: throughout study
measure: Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
timeFrame: at any time on study
measure: Change in FACT-G total score from baseline to EOTP
timeFrame: from baseline to EOTP
measure: 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
timeFrame: throughout study
measure: Change in EQ-5D Thermometer from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Change in BSI Anxiety scale score from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Change in BSI Depression scale score from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Change in number of caregiver hours from baseline to EOTP
timeFrame: from baseline to EOTP
measure: Incidence of a confirmed antibody formation to darbepoetin alfa
timeFrame: throughout study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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 Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164.