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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera 6.3 micrograms/kg | Experimental |
| |
| Mircera 9 micrograms/kg | Experimental |
| |
| Mircera 12 micrograms/kg | Experimental |
| |
| Darbepoetin alfa | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin alfa | Drug | According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Hb change from baseline | Weeks 5-13 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Hb therapeutic range, average Hb values, hematopoietic response. | Days 2-85 | |
| Red blood cell (RBC) transfusions | Weeks 5-13 | |
| Adverse events (AEs), laboratory parameters, premature withdrawals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bentleigh | VIC 3165 | Australia | ||||
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| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | 6.3 micrograms/kg every 3 weeks |
|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | 9 micrograms/kg every 3 weeks |
|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | 12 micrograms/kg every 3 weeks |
|
| Throughout study |
| Kurralta Park |
| 5037 |
| Australia |
| Milton | 4064 | Australia |
| Linz | 4020 | Austria |
| Salzburg | 5020 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1145 | Austria |
| Vienna | 1160 | Austria |
| Aalst | 9300 | Belgium |
| Edegem | 2650 | Belgium |
| Liège | 4000 | Belgium |
| Toronto | Ontario | M4C 3E7 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Brno | 639 00 | Czechia |
| Hradec Králové | 500 05 | Czechia |
| Ostrava | 708 52 | Czechia |
| Prague | 180 01 | Czechia |
| Tallinn | 11619 | Estonia |
| Tartu | 51003 | Estonia |
| Helsinki | 00029 | Finland |
| Bobigny | 93009 | France |
| Caen | 14076 | France |
| Dijon | 21079 | France |
| Lyon | 69437 | France |
| Paris | 75571 | France |
| Pessac | 33600 | France |
| Pierre-Bénite | 69495 | France |
| Saint-Pierre | 97448 | France |
| Gauting | 82131 | Germany |
| Hamburg | 21075 | Germany |
| Hamburg | 22045 | Germany |
| Heidelberg | 69126 | Germany |
| Karlsruhe | 76137 | Germany |
| Trier | 54290 | Germany |
| Athens | 11527 | Greece |
| Heraklion | 71110 | Greece |
| Larissa | 41 110 | Greece |
| Thessaloniki | 56429 | Greece |
| Thessaloniki | 57001 | Greece |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Budapest | 1529 | Hungary |
| Deszk | 6772 | Hungary |
| Mátraháza | 3233 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Székesfehérvár | 8001 | Hungary |
| Genova | 16132 | Italy |
| Legnago | 37045 | Italy |
| Novara | 28100 | Italy |
| Pavia | 27100 | Italy |
| Ravenna | 48100 | Italy |
| San Giovanni Rotondo | 71013 | Italy |
| Sassari | 07100 | Italy |
| Bydgoszcz | 85-326 | Poland |
| Elblag | 82-300 | Poland |
| Otwock | 05-400 | Poland |
| Poznan | 60-569 | Poland |
| Radom | 26-617 | Poland |
| Wroclaw | 53-439 | Poland |
| Włocławek | 87-800 | Poland |
| Barcelona | 08003 | Spain |
| Barcelona | 08036 | Spain |
| Girona | 17007 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28041 | Spain |
| Madrid | 28046 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| C508420 | continuous erythropoietin receptor activator |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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