Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: July 7, 2008 at 2:35:34 PM