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Trial information
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving Chemotherapy.
Status: Completed
Protocol number: NA17101
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of subcutaneous Mircera on hemoglobin level/correction in anemic patients with Stage IIIB or IV non-small-cell lung carcinoma receiving antineoplastic therapy
Brief summary: This study will assess the efficacy and safety of different subcutaneous (sc) doses and dosing frequencies of Mircera in patients with non-small cell lung cancer (NSCLC) and anemia who are receiving chemotherapy. The anticipated time on study treatment is less than 3 months and the target sample size is 100-500 individuals.
Target sample size is 210.
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. Efficacy:Time-adjusted average hemoglobin value between baseline and end of initial treatment
Key secondary outcomes: 1. Efficacy: Change from baseline in Hb, Hct, reticulocyte count, Hb and hematopoietic response, transfusion requirements
Safety: Vital signs, AEs, lab values
Inclusion criteria: - adult patients >=18 years of age;
- anemia;
- NSCLC;
- receiving chemotherapy.
Exclusion criteria: - women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug in the 30 days preceding the first dose of study medication.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:Australia - Adelaide
- Brisbane
- Melbourne
Belgium Canada - Surrey, BC
- Vancouver, BC
- Ottawa, ON
- Montreal, QC
- Sainte-Foy, QC
China Germany - Gauting
- Grosshansdorf
- Hamburg
- Heidelberg
- Trier
Hungary - Budapest
- Nyiregyhaza
- Szombathely
Italy Lithuania Mexico Panama Poland - Olsztyn
- Otwock
- Poznan
- Warszawa
Spain Taiwan United States - Bakersfield, CA
- Fullerton, CA
- Greenbrae, CA
- Long Beach, CA
- Los Angeles, CA
- Northridge, CA
- Oceanside, CA
- Pomona, CA
- Porterville, CA
- Santa Barbara, CA
- Vista, CA
- Colorado Springs, CO
- Des Moines, IA
- Tupelo, MS
- Great Falls, MT
- Rochester, NY
- Rockville Centre, NY
- Hickory , NC
- Bismarck, ND
- Canton, OH
- Kingston , PA
- Philadelphia, PA
- Aiken, SC
- Memphis , TN
- Houston, TX
- Bennington, VT
- Tacoma, WA
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