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Clinical Trials/NCT00327535
NCT00327535CompletedPhase 2

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

Hoffmann-La Roche0 sites153 target enrollmentStarted: May 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
153
Primary Endpoint
Average Hb change from baseline

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Mircera 6.3 micrograms/kg

Experimental

Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)

Mircera 9 micrograms/kg

Experimental

Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)

Mircera 12 micrograms/kg

Experimental

Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)

Darbepoetin alfa

Active Comparator

Intervention: Darbepoetin alfa (Drug)

Outcomes

Primary Outcomes

Average Hb change from baseline

Time Frame: Weeks 5-13

Secondary Outcomes

  • Target Hb therapeutic range, average Hb values, hematopoietic response.(Days 2-85)
  • Red blood cell (RBC) transfusions(Weeks 5-13)
  • Adverse events (AEs), laboratory parameters, premature withdrawals(Throughout study)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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