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Study Complete
Sponsor ID
20010103

Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Sponsor ID
20010103
Clinicaltrials.gov ID
NCT00091858
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
1000
Additional Study Details

Protocol Summary

Primary Outcome Measures

Occurrences of red blood cell transfusion

Timeframe: from study day 29 (week 5) to week 17

Secondary Outcome Measures

Incidence of first red blood cell transfusion

Timeframe: from week 5 (study day 29) to week 17 (study day 119)

Change in hemoglobin concentration measured

Timeframe: from baseline (study day 1) to EOTP

Adverse events and serious adverse events

Timeframe: throughout study for subjects who received at least 1 dose of investigational product

Survival

Timeframe: deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product

Incidence, if any, of neutralizing antibody formation to investigational product

Timeframe: throughout study for subjects who received at least 1 dose of investigational product

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
  • Cancer - Other
    • Sex
    All
    Trial Dates
    Apr 2004 - Oct 2006
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - subjects with non-myeloid malignancies - anemia due to cancer - ECOG status 0 to 2 - greater than or equal to 4-month expectancy - greater than or equal to 18 years and of legal age for informed consent - screening hemoglobin concentration less than or equal to 11.0g/dL - adequate serum folate and vitamin B12 - adequate renal and liver function - written informed consent
    Exclusion Criteria:
    - subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization - in complete remission, as determined by the investigator - subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc) - documented history of pure red cell aplasia - Known history of seizure disorder - cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia - uncontrolled hypertension - clinically significant systemic infection or chronic inflammatory disease present at the time of randomization - iron deficiency - known positive test for HIV infection - previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa - received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization - less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority - pregnant or breast feeding - subject of reproductive potential who is not using adequate contraceptive precautions - known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product - previously randomized into this study - concerns for subject's compliance with the protocol procedures