Trial information
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
Status: Terminated
Protocol number: NH19960
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official 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
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. Target sample size is 153.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Average Hb change from baseline Time frame: Weeks 5-13
Key secondary outcomes: 1. Target Hb therapeutic range, average Hb values, hematopoietic response. Time frame: Days 2-85
2. RBC transfusions Time frame: Weeks 5-13
3. AEs, laboratory parameters, premature withdrawals Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 05/17/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Austria
Belgium
China
Czech Republic
- Brno
- Hradec Kralove
- Ostrava
Estonia
Finland
France
Germany
Hungary
- Budapest
- Deszk
- Mátraháza
- Szekesfehervar
Poland
- Bydgoszcz
- Otwock
- Poznan
- Wloclawek
Spain
- Barcelona
- Girona
- Madrid
- Zaragoza
