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A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

NCT00327535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2016-08-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Darbepoetin alfa

According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

6.3 micrograms/kg every 3 weeks

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

9 micrograms/kg every 3 weeks

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

12 micrograms/kg every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327535 on ClinicalTrials.gov