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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00327535




Registration number
NCT00327535
Ethics application status
Date submitted
16/05/2006
Date registered
18/05/2006
Date last updated
11/08/2016

Titles & IDs
Public title
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
Scientific 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
Secondary ID [1] 0 0
NH19960
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]

Experimental: Mircera 6.3 micrograms/kg -

Experimental: Mircera 9 micrograms/kg -

Experimental: Mircera 12 micrograms/kg -

Active comparator: Darbepoetin alfa -


Treatment: Drugs: Darbepoetin alfa
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
6.3 micrograms/kg every 3 weeks

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
9 micrograms/kg every 3 weeks

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
12 micrograms/kg every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Hb change from baseline
Timepoint [1] 0 0
Weeks 5-13
Secondary outcome [1] 0 0
Target Hb therapeutic range, average Hb values, hematopoietic response.
Timepoint [1] 0 0
Days 2-85
Secondary outcome [2] 0 0
Red blood cell (RBC) transfusions
Timepoint [2] 0 0
Weeks 5-13
Secondary outcome [3] 0 0
Adverse events (AEs), laboratory parameters, premature withdrawals
Timepoint [3] 0 0
Throughout study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- East Bentleigh
Recruitment hospital [2] 0 0
- Kurralta Park
Recruitment hospital [3] 0 0
- Milton
Recruitment postcode(s) [1] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
4064 - Milton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Aalst
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Brno
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Hradec Kralove
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Ostrava
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha
Country [12] 0 0
Estonia
State/province [12] 0 0
Tallin
Country [13] 0 0
Estonia
State/province [13] 0 0
Tartu
Country [14] 0 0
Finland
State/province [14] 0 0
Helsinki
Country [15] 0 0
France
State/province [15] 0 0
Bobigny
Country [16] 0 0
France
State/province [16] 0 0
Caen
Country [17] 0 0
France
State/province [17] 0 0
Dijon
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Pessac
Country [21] 0 0
France
State/province [21] 0 0
Pierre Benite
Country [22] 0 0
France
State/province [22] 0 0
Saint Pierre
Country [23] 0 0
Germany
State/province [23] 0 0
Gauting
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Heidelberg
Country [26] 0 0
Germany
State/province [26] 0 0
Karlsruhe
Country [27] 0 0
Germany
State/province [27] 0 0
Trier
Country [28] 0 0
Greece
State/province [28] 0 0
Athens
Country [29] 0 0
Greece
State/province [29] 0 0
Heraklion
Country [30] 0 0
Greece
State/province [30] 0 0
Larissa
Country [31] 0 0
Greece
State/province [31] 0 0
Thessaloniki
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Hong Kong
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Deszk
Country [35] 0 0
Hungary
State/province [35] 0 0
Mátraháza
Country [36] 0 0
Hungary
State/province [36] 0 0
Nyiregyhaza
Country [37] 0 0
Hungary
State/province [37] 0 0
Szekesfehervar
Country [38] 0 0
Italy
State/province [38] 0 0
Genova
Country [39] 0 0
Italy
State/province [39] 0 0
Legnago
Country [40] 0 0
Italy
State/province [40] 0 0
Novara
Country [41] 0 0
Italy
State/province [41] 0 0
Pavia
Country [42] 0 0
Italy
State/province [42] 0 0
Ravenna
Country [43] 0 0
Italy
State/province [43] 0 0
San Giovanni Rotondo
Country [44] 0 0
Italy
State/province [44] 0 0
Sassari
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
State/province [46] 0 0
Elblag
Country [47] 0 0
Poland
State/province [47] 0 0
Otwock
Country [48] 0 0
Poland
State/province [48] 0 0
Poznan
Country [49] 0 0
Poland
State/province [49] 0 0
Radom
Country [50] 0 0
Poland
State/province [50] 0 0
Wloclawek
Country [51] 0 0
Poland
State/province [51] 0 0
Wroclaw
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Girona
Country [54] 0 0
Spain
State/province [54] 0 0
La Laguna
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00327535
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00327535