Clinical trial NCT00327535: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* \>=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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Average Hb change from baseline
timeFrame: Weeks 5-13
Secondary outcomes:
measure: Target Hb therapeutic range, average Hb values, hematopoietic response.
timeFrame: Days 2-85
measure: Red blood cell (RBC) transfusions
timeFrame: Weeks 5-13
measure: Adverse events (AEs), laboratory parameters, premature withdrawals
timeFrame: Throughout study
Other outcomes:
Locations:
city: East Bentleigh
country: Australia
city: Kurralta Park
country: Australia
city: Milton
country: Australia
city: Linz
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Edegem
country: Belgium
city: Liege
country: Belgium
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Tallin
country: Estonia
city: Tartu
country: Estonia
city: Helsinki
country: Finland
city: Bobigny
country: France
city: Caen
country: France
city: Dijon
country: France
city: Lyon
country: France
city: Paris
country: France
city: Pessac
country: France
city: Pierre Benite
country: France
city: Saint Pierre
country: France
city: Gauting
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Karlsruhe
country: Germany
city: Trier
country: Germany
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Larissa
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Deszk
country: Hungary
city: Mátraháza
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szekesfehervar
country: Hungary
city: Genova
country: Italy
city: Legnago
country: Italy
city: Novara
country: Italy
city: Pavia
country: Italy
city: Ravenna
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Sassari
country: Italy
city: Bydgoszcz
country: Poland
city: Elblag
country: Poland
city: Otwock
country: Poland
city: Poznan
country: Poland
city: Radom
country: Poland
city: Wloclawek
country: Poland
city: Wroclaw
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: La Laguna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: