Trial record 20 of 1803 for:
"Anemia"
Darbepoetin Alfa and Anemia of Cancer
This study has been terminated.
(slow enrollment and change in product development strategy)
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00989092
First received: October 1, 2009
Last updated: October 8, 2009
Last verified: October 2009
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Purpose
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 subjects with nonmyeloid malignancies who were not receiving chemotherapy. Subjects 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Anemia of Cancer Cancer Carcinoma Neoplasms Non-Myeloid Malignancies |
Biological: darbepoetin alfa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- to estimate the difference in number of hospital days, number of subject hospitalized, and number of hospitalizations over 12 weeks between subjects by randomized treatment group [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- to estimate the difference in total costs (direct and indirect such as hospitalization days, lost time from work) over 12 weeks between subjects who have been treated with darbepoetin alfa and those w [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale scores from baseline at week 13 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- to estimate the difference in change in health-related quality of life (HRQOL) at week 13 by randomized treatment group [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- to estimate the difference in percentage of subjects with hemoglobin response, hematopoietic response, and change in hemoglobin from baseline between the 2 treatment arms at week 13 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- to estimate the difference in the number and percentage of subjects between the 2 treatment arms who receive any transfusions, the number of units transfused, and the number of days with at least 1 RBC transfusion during weeks 1 to 12, and 5 to 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- to further assess the safety of darbepoetin alfa with every other week dosing for up to 21 weeks [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 287 |
| Study Start Date: | May 2002 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Observational Group
Subjects in the observation group were to be evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was to be administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 mcg/kg once every 2 weeks beginning with the first visit after the test period at which the subject's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 mcg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in subjects with a hemoglobin change from baseline of less than 1.0 g/dL.
|
Biological: darbepoetin alfa
Darbepoetin alfa could be initiated at a dose of 3.0 mcg/kg once every 2 weeks beginning with the first visit after the test period at which the subject's hemoglobin concentration was less than or equal to 11.0 g/dL
|
|
Active Comparator: 21 week treatment group
Subjects in the treatment group were to receive darbepoetin alfa subcutaneously (SC) at a dose of 3.0 mcg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 mcg/kg once every 2 weeks) or at week 13 (to 9.0 mcg/kg once every 2 weeks) in subjects with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7
|
Biological: darbepoetin alfa
3.0 mcg/kg once every 2 weeks for 21 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- nonmyeloid malignancies (including lymphocytic leukemias)
- anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate liver and renal functions
- 18 years or older
Exclusion Criteria:
- history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
- acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
- known hematologic disorders that could cause anemia
- inflammatory or cardiac disorders
- previous positive antibody response to any erythropoietic agent
- history of pure red cell aplasia
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00989092 History of Changes |
| Other Study ID Numbers: | 20000219 |
| Study First Received: | October 1, 2009 |
| Last Updated: | October 8, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
anemia of cancer darbepoetin alfa Aranesp |
Additional relevant MeSH terms:
|
Anemia Neoplasms Carcinoma Hematologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Darbepoetin alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013