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: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Anemia, Neoplasms
Drug: epoetin beta [NeoRecormon]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1060
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: epoetin beta [NeoRecormon]
As prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Anemic cancer patients receiving NeoRecormon (epoetin beta)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168349

Locations
France
Neuilly-sur-seine, France, 92521
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01168349     History of Changes
Other Study ID Numbers: ML22733
Study First Received: July 21, 2010
Last Updated: April 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014