A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
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
1 other identifier
interventional
153
13 countries
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
Shorter than P25 for phase_2
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedAugust 11, 2016
August 1, 2016
1 year
May 16, 2006
August 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Average Hb change from baseline
Weeks 5-13
Secondary Outcomes (3)
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
Throughout study
Study Arms (4)
Mircera 6.3 micrograms/kg
EXPERIMENTALMircera 9 micrograms/kg
EXPERIMENTALMircera 12 micrograms/kg
EXPERIMENTALDarbepoetin alfa
ACTIVE COMPARATORInterventions
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
6.3 micrograms/kg every 3 weeks
Eligibility Criteria
You may qualify if:
- \>=18 years of age;
- 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.
You may not qualify if:
- transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
- iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
- prior treatment with Mircera.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Unknown Facility
East Bentleigh, VIC 3165, Australia
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Kurralta Park, 5037, Australia
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Milton, 4064, Australia
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vienna, 1145, Austria
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Vienna, 1160, Austria
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Aalst, 9300, Belgium
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Edegem, 2650, Belgium
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Liège, 4000, Belgium
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Toronto, Ontario, M4C 3E7, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Brno, 639 00, Czechia
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Hradec Králové, 500 05, Czechia
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Ostrava, 708 52, Czechia
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Prague, 180 01, Czechia
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Tallinn, 11619, Estonia
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Tartu, 51003, Estonia
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Helsinki, 00029, Finland
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Bobigny, 93009, France
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Caen, 14076, France
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Dijon, 21079, France
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Lyon, 69437, France
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Paris, 75571, France
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Pessac, 33600, France
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Pierre-Bénite, 69495, France
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Saint-Pierre, 97448, France
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Gauting, 82131, Germany
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Hamburg, 21075, Germany
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Hamburg, 22045, Germany
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Heidelberg, 69126, Germany
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Karlsruhe, 76137, Germany
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Trier, 54290, Germany
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Athens, 11527, Greece
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Heraklion, 71110, Greece
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Larissa, 41 110, Greece
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Thessaloniki, 56429, Greece
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Thessaloniki, 57001, Greece
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Budapest, 1529, Hungary
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Deszk, 6772, Hungary
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Mátraháza, 3233, Hungary
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Nyíregyháza, 4400, Hungary
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Székesfehérvár, 8001, Hungary
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Genova, 16132, Italy
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Legnago, 37045, Italy
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Novara, 28100, Italy
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Pavia, 27100, Italy
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Ravenna, 48100, Italy
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San Giovanni Rotondo, 71013, Italy
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Sassari, 07100, Italy
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Bydgoszcz, 85-326, Poland
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Elblag, 82-300, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, Poland
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Radom, 26-617, Poland
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Wroclaw, 53-439, Poland
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Włocławek, 87-800, Poland
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Girona, 17007, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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San Cristóbal de La Laguna, 38320, Spain
Unknown Facility
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2006
First Posted
May 18, 2006
Study Start
May 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
August 11, 2016
Record last verified: 2016-08