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Darbepoetin alfa

Darbepoetin Alfa

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Amgen

Global Development Leader

Behaviors and Mental Disorders

Carcinoma

Quality of Life

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.

Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.

darbepoetin alfa

This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).

Darbepoetin Alfa and Anemia of Cancer

A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer

Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.

Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.

Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12

The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.

The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.

The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.

The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.

The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).

Number of participants with at least one RBC transfusion during Weeks 1 to 12.

The average number of standard units of red blood cells transfused during Weeks 1 to 12.

The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.

The number of participants with at least one RBC transfusion during weeks 5 to 12.

The number of standard units of RBCs transfused during Weeks 5 to 12.

The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Treatment Arm

Participants in the observation group who received darbepoetin alfa, initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Adverse events for participants in this group could have been reported at any time during the study; and therefore, may have occurred before darbepoetin alfa administration.

Observation Arm Treated

Participants in the observation group who did not receive any darbepoetin alfa treatment.

Observation Arm Not Treated

Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.

Darbepoetin Alfa 3 μg/kg

Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.

Observation

Total

Demographic data are provided for the Efficacy Analysis Set (all patients who were randomized to the observation group or patients who were randomized to the treatment group and received at least 1 dose of investigational product).

Age, Continuous

Sex: Female, Male

White

Black

Asian

Other

Race/Ethnicity, Customized

Study Director

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.

Number of Participants Hospitalized During the Test Period

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and were included in the hospital bill database. Participants who were not hospitalized had a cost of $0 imputed.

Total Hospital Costs During the Test Period

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Participants also needed to have completed the baseline and at least 1 post-baseline FACT-Fatigue questionaire. Last Value Carried Forward (LVCF) imputation used.

Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.

Hemoglobin Response During the Test Period

Hematopoietic Response During the Test Period

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion. LVCF imputation was used.

Change From Baseline in Hemoglobin Level

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm with available data.

Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period

Days of Hospitalization During the Test Period

Number of Hospitalizations During the Test Period

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.

Number of Units of Red Blood Cells Transfused During the Test Period

Number of Days of Red Blood Cell Transfusions During the Test Period

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).

Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12

Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of week 5 (study day 29).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer	NCT00095277	Anemia	Darbepoetin Alf...	18 Years -	Amgen
Darbepoetin Alfa and Anemia of Cancer	NCT00989092	Anemia Anemia of Cance... Cancer Carcinoma Neoplasms Non-Myeloid Mal...	darbepoetin alf...	18 Years -	Amgen

Spots Global Cancer Trial Database for anemia of cancer