Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin alfa 500 mcg - Group A | Experimental |
| |
| Darbepoetin alfa 2.25 mcg/kg - Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin alfa - 2.25 mcg/kg | Drug | Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) | from week 5 to EOTP |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP | from week 5 to EOTP | |
| Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, | ||
| 22081263 | Result | Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus >/= 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13. | |
| 16478746 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Darbepoetin alfa - 500mcg | Drug | Darbepoetin alfa 500mcg Q3W dosing / placebo QW |
|
| from week 1 (day 1) to EOTP |
| Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP | from week 1 to EOTP |
| Change in FACT-G Physical Well-being subscale from baseline to EOTP | from baseline to EOTP |
| Change in hemoglobin from baseline to EOTP | from baseline to EOTP |
| Change in FACT-Fatigue subscale score from baseline to EOTP | from baseline to EOTP |
| Change in FACT-G total score from baseline to EOTP | from baseline to EOTP |
| Change in EQ-5D Thermometer from baseline to EOTP | from baseline to EOTP |
| Change in BSI Anxiety scale score from baseline to EOTP | from baseline to EOTP |
| Change in BSI Depression scale score from baseline to EOTP | from baseline to EOTP |
| Incidence and severity of adverse events | throughout study |
| Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study | at any time on study |
| Change in number of caregiver hours from baseline to EOTP | from baseline to EOTP |
| 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 |
| Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences | throughout study |
| Incidence of a confirmed antibody formation to darbepoetin alfa | throughout study |
| Result |
| Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84. doi: 10.1093/jnci/djj053. |
| 19728887 | Result | Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311. doi: 10.1186/1471-2407-9-311. |
| FDA-approved Drug Labeling | View source |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |