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An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01168349
First received: July 21, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes

July 21, 2010
June 3, 2013
January 2010
December 2010   (final data collection date for primary outcome measure)
To evaluate in daily routine practice the clinical benefit (i.e. transfusion avoidance, maintenance of general health status, professional and social activity) of NeoRecormon in anemic cancer patients, according to early response to treatment [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01168349 on ClinicalTrials.gov Archive Site
  • To assess baseline characteristics of patients [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • To assess the pattern of use of NeoRecormon in real-life practice and adherence to current guidelines [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • To assess hemoglobin level evolution [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • To assess the iron and vitamin status of patients [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • To assess adverse events: pure red cell aplasia and thromboembolic events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment

This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Anemic cancer patients receiving NeoRecormon (epoetin beta)
Anemia, Neoplasms
Drug: epoetin beta [NeoRecormon]
As prescribed by physician
Cohort
Intervention: Drug: epoetin beta [NeoRecormon]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1060
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
  • Patients for whom treatment with epoetin beta is started at the inclusion visit
  • Life expectancy >/=6 months according to the physician
  • Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit

Exclusion Criteria:

  • Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment
  • Participation in a clinical trial in onco-hematology
  • Patients with myelodysplasia
  • Patients with more than one active malignancy at the time of enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01168349
ML22733
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP