| June 21, 2005 |
| May 7, 2009 |
| August 2004 |
| January 2007 (final data collection date for primary outcome measure) |
| Incidence of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ] |
| Incidence of adverse events |
| Complete list of historical versions of study NCT00115167 on ClinicalTrials.gov Archive Site |
- Confirmed antibody formation to investigational product [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Deaths on study [ Time Frame: on study ] [ Designated as safety issue: Yes ]
- Laboratory parameters [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Vital signs (blood pressure) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Change in PRO scores [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
|
- Confirmed antibody formation to investigational product
- Deaths on study
- Laboratory parameters
- Vital signs (blood pressure)
- Change in PRO scores from baseline
|
| |
| A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study |
| A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer |
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
|
|
- Drug: Placebo
- Drug: Darbepoetin alfa
|
| |
| Smith RE Jr, Aapro MS, Ludwig H, Pintér T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. Epub 2008 Jan 28. |
| |
| Completed |
| 371 |
| March 2007 |
| January 2007 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00115167 |
| Global Development Leader, Amgen Inc. |
| 20020149 |
| Amgen |
|
|
|
| Amgen |
| May 2009 |
