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

NCT ID: NCT00327535

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mircera 6.3 micrograms/kg

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

6.3 micrograms/kg every 3 weeks

Mircera 9 micrograms/kg

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

9 micrograms/kg every 3 weeks

Mircera 12 micrograms/kg

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

12 micrograms/kg every 3 weeks

Darbepoetin alfa

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type DRUG

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

Interventions

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Darbepoetin alfa

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

Intervention Type DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

6.3 micrograms/kg every 3 weeks

Intervention Type DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

9 micrograms/kg every 3 weeks

Intervention Type DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

12 micrograms/kg every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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East Bentleigh, , Australia

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Kurralta Park, , Australia

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Milton, , Australia

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Aalst, , Belgium

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Edegem, , Belgium

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Liège, , Belgium

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Brno, , Czechia

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Hradec Králové, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Helsinki, , Finland

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Bobigny, , France

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Caen, , France

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Dijon, , France

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Lyon, , France

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Paris, , France

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Pessac, , France

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Pierre-Bénite, , France

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Saint-Pierre, , France

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Gauting, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Karlsruhe, , Germany

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Trier, , Germany

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Athens, , Greece

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Heraklion, , Greece

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Larissa, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Hong Kong, , Hong Kong

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Hong Kong, , Hong Kong

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Budapest, , Hungary

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Deszk, , Hungary

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Mátraháza, , Hungary

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Nyíregyháza, , Hungary

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Székesfehérvár, , Hungary

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Genova, , Italy

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Legnago, , Italy

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Novara, , Italy

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Pavia, , Italy

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Ravenna, , Italy

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San Giovanni Rotondo, , Italy

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Sassari, , Italy

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Bydgoszcz, , Poland

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Elblag, , Poland

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Otwock, , Poland

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Poznan, , Poland

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Radom, , Poland

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Wroclaw, , Poland

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Włocławek, , Poland

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Barcelona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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San Cristóbal de La Laguna, , Spain

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Zaragoza, , Spain

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Countries

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

Other Identifiers

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NH19960

Identifier Type: -

Identifier Source: org_study_id

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