Trial Information

Summary: 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 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. 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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2006

Trial Registration Date: 05/17/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:27:14 PM