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Completed

NCT Number: NCT00327535

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

East Bentleigh, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

darbepoetin alfa

Drug

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

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

6.3 micrograms/kg every 3 weeks

Primary outcomes

  1. Average Hb change from baseline

    Time frame: Weeks 5-13

Secondary outcomes

  1. Target Hb therapeutic range, average Hb values, hematopoietic response.

    Time frame: Days 2-85

  2. Red blood cell (RBC) transfusions

    Time frame: Weeks 5-13

  3. Adverse events (AEs), laboratory parameters, premature withdrawals

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 18, 2006
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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