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

Phase 2

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Darbepoetin alfa

• Registration Number: NCT00327535
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-16
• Study First Submitted QC: 2006-05-16
• Study First Posted: 2006-05-18
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mircera 9 micrograms/kg	methoxy polyethylene glycol-epoetin beta [Mircera]	-
Mircera 12 micrograms/kg	methoxy polyethylene glycol-epoetin beta [Mircera]	-
Darbepoetin alfa	Darbepoetin alfa	-
Mircera 6.3 micrograms/kg	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Average Hb change from baseline	Weeks 5-13

Secondary Outcome Measures

Name	Time	Method
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