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

August 9, 2016 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Bentleigh, Australia, VIC 3165
      • Kurralta Park, Australia, 5037
      • Milton, Australia, 4064
  • Austria
      • Linz, Austria, 4020
      • Salzburg, Austria, 5020
      • Wien, Austria, 1160
      • Wien, Austria, 1090
      • Wien, Austria, 1145
  • Belgium
      • Aalst, Belgium, 9300
      • Edegem, Belgium, 2650
      • Liege, Belgium, 4000
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M4C 3E7
  • Czech Republic
      • Brno, Czech Republic, 639 00
      • Hradec Kralove, Czech Republic, 500 05
      • Ostrava, Czech Republic, 708 52
      • Praha, Czech Republic, 180 01
  • Estonia
      • Tallin, Estonia, 11619
      • Tartu, Estonia, 51003
  • Finland
      • Helsinki, Finland, 00029
  • France
      • Bobigny, France, 93009
      • Caen, France, 14076
      • Dijon, France, 21079
      • Lyon, France, 69437
      • Paris, France, 75571
      • Pessac, France, 33600
      • Pierre Benite, France, 69495
      • Saint Pierre, France, 97448
  • Germany
      • Gauting, Germany, 82131
      • Hamburg, Germany, 21075
      • Hamburg, Germany, 22045
      • Heidelberg, Germany, 69126
      • Karlsruhe, Germany, 76137
      • Trier, Germany, 54290
  • Greece
      • Athens, Greece, 11527
      • Heraklion, Greece, 71110
      • Larissa, Greece, 41 110
      • Thessaloniki, Greece, 56429
      • Thessaloniki, Greece, 57001
  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong, 852
  • Hungary
      • Budapest, Hungary, 1529
      • Deszk, Hungary, 6772
      • Mátraháza, Hungary, 3233
      • Nyiregyhaza, Hungary, 4400
      • Szekesfehervar, Hungary, 8001
  • Italy
      • Genova, Italy, 16132
      • Legnago, Italy, 37045
      • Novara, Italy, 28100
      • Pavia, Italy, 27100
      • Ravenna, Italy, 48100
      • San Giovanni Rotondo, Italy, 71013
      • Sassari, Italy, 07100
  • Poland
      • Bydgoszcz, Poland, 85-326
      • Elblag, Poland, 82-300
      • Otwock, Poland, 05-400
      • Poznan, Poland, 60-569
      • Radom, Poland, 26-617
      • Wloclawek, Poland, 87-800
      • Wroclaw, Poland, 53-439
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Girona, Spain, 17007
      • La Laguna, Spain, 38320
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Zaragoza, Spain, 50009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Darbepoetin alfa
Drug: Darbepoetin alfa
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
Experimental: Mircera 6.3 micrograms/kg
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
Experimental: Mircera 9 micrograms/kg
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
Experimental: Mircera 12 micrograms/kg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average Hb change from baseline
Time Frame: Weeks 5-13
Weeks 5-13

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 16, 2006

First Submitted That Met QC Criteria

May 16, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH19960

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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