Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110955
First received: May 16, 2005
Last updated: January 14, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Non-Myeloid Malignancies |
Drug: Darbepoetin alfa Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
- Number of RBC transfusions from week 5 to EOTP [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
- Change in FACT-Fatigue subscale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Change in FACT-G Physical Well-being subscale from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Incidence and severity of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study [ Time Frame: at any time on study ] [ Designated as safety issue: Yes ]
- Change in FACT-G total score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- 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 [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Change in EQ-5D Thermometer from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Change in BSI Anxiety scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Change in BSI Depression scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Change in number of caregiver hours from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
- Incidence of a confirmed antibody formation to darbepoetin alfa [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
| Enrollment: | 391 |
| Study Start Date: | February 2004 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Darbepoetin alfa - Group A |
Drug: Darbepoetin alfa
Q3W 300 mcg darbepoetin alfa
|
| Placebo Comparator: Placebo- Group B |
Drug: Placebo
Q3W dosing of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00110955 History of Changes |
| Other Study ID Numbers: | 20030232 |
| Study First Received: | May 16, 2005 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Non-myeloid malignancy Chemotherapy-induced anemia |
Additional relevant MeSH terms:
|
Anemia Neoplasms Hematologic Diseases Darbepoetin alfa |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013