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Spots Global Cancer Trial Database for A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

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Trial Identification

Brief Title: A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

Official Title: A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy

Study ID: NCT00327535

Conditions

Anemia

Study Description

Brief Summary: This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, East Bentleigh, , Australia

, Kurralta Park, , Australia

, Milton, , Australia

, Linz, , Austria

, Salzburg, , Austria

, Wien, , Austria

, Wien, , Austria

, Wien, , Austria

, Aalst, , Belgium

, Edegem, , Belgium

, Liege, , Belgium

, Toronto, Ontario, Canada

, Toronto, Ontario, Canada

, Brno, , Czech Republic

, Hradec Kralove, , Czech Republic

, Ostrava, , Czech Republic

, Praha, , Czech Republic

, Tallin, , Estonia

, Tartu, , Estonia

, Helsinki, , Finland

, Bobigny, , France

, Caen, , France

, Dijon, , France

, Lyon, , France

, Paris, , France

, Pessac, , France

, Pierre Benite, , 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

, Nyiregyhaza, , Hungary

, Szekesfehervar, , 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

, Wloclawek, , Poland

, Wroclaw, , Poland

, Barcelona, , Spain

, Barcelona, , Spain

, Girona, , Spain

, La Laguna, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Zaragoza, , Spain

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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