A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
NCT ID: NCT00327535
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2006-05-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mircera 6.3 micrograms/kg
methoxy polyethylene glycol-epoetin beta [Mircera]
6.3 micrograms/kg every 3 weeks
Mircera 9 micrograms/kg
methoxy polyethylene glycol-epoetin beta [Mircera]
9 micrograms/kg every 3 weeks
Mircera 12 micrograms/kg
methoxy polyethylene glycol-epoetin beta [Mircera]
12 micrograms/kg every 3 weeks
Darbepoetin alfa
Darbepoetin alfa
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
Interventions
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Darbepoetin alfa
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
methoxy polyethylene glycol-epoetin beta [Mircera]
6.3 micrograms/kg every 3 weeks
methoxy polyethylene glycol-epoetin beta [Mircera]
9 micrograms/kg every 3 weeks
methoxy polyethylene glycol-epoetin beta [Mircera]
12 micrograms/kg every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
* myelosuppressive chemotherapy scheduled for at least 9 weeks;
* anemia at screening visit.
Exclusion Criteria
* iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
* prior treatment with Mircera.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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East Bentleigh, , Australia
Kurralta Park, , Australia
Milton, , Australia
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Aalst, , Belgium
Edegem, , Belgium
Liège, , Belgium
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Brno, , Czechia
Hradec Králové, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Helsinki, , Finland
Bobigny, , France
Caen, , France
Dijon, , France
Lyon, , France
Paris, , France
Pessac, , France
Pierre-Bénite, , France
Saint-Pierre, , France
Gauting, , Germany
Hamburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Karlsruhe, , Germany
Trier, , Germany
Athens, , Greece
Heraklion, , Greece
Larissa, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Budapest, , Hungary
Deszk, , Hungary
Mátraháza, , Hungary
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Genova, , Italy
Legnago, , Italy
Novara, , Italy
Pavia, , Italy
Ravenna, , Italy
San Giovanni Rotondo, , Italy
Sassari, , Italy
Bydgoszcz, , Poland
Elblag, , Poland
Otwock, , Poland
Poznan, , Poland
Radom, , Poland
Wroclaw, , Poland
Włocławek, , Poland
Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
San Cristóbal de La Laguna, , Spain
Zaragoza, , Spain
Countries
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Other Identifiers
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NH19960
Identifier Type: -
Identifier Source: org_study_id
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