A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anemia, Cancer
Both
Anemia, Cancer
Trial Information
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Inclusion Criteria:
- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer
protocol
Exclusion Criteria:
- Subjects currently receiving or planned to receive cytotoxic chemotherapy or
myelosuppressive radiotherapy
- Subjects who have other diagnoses not related to the cancer which can cause anemia
- 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 enrollment
- Subject of reproductive potential who is not using adequate contraceptive precautions
- Concerns for subject's compliance with the protocol procedures
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events
Outcome Time Frame:
throughout study
Safety Issue:
Yes
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Slovakia: Štátny ústav pre kontrolu lieciv
Study ID:
20020149
NCT ID:
NCT00115167
Start Date:
August 2004
Completion Date:
March 2007
Related Keywords:
- Anemia
- Cancer
- Oncology
- Cancer-related anemia
- Anemia
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